The DURABLE Trial: Evaluating the Durability of Starter I... | NCT00279201 | Trialant
NCT00279201
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Feb 21, 2011Estimated
Enrollment
2,091Actual
Phase
Phase 4
Conditions
Diabetes Mellitus, Type 2
Interventions
Insulin glargine
Lispro Low Mix
Lispro Mid Mix
Lispro
Countries
United States
Argentina
Australia
Brazil
Canada
Greece
Hungary
India
Netherlands
Puerto Rico
Romania
Spain
Protocol Section
Identification Module
NCT ID
NCT00279201
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
10455
Secondary IDs
ID
Type
Description
Link
F3Z-US-IOOV
Other Identifier
Eli Lilly and Company
Brief Title
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
Official Title
The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
Acronym
IOOV
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2005
Primary Completion Date
Nov 2009Actual
Completion Date
Nov 2009Actual
First Submitted Date
Dec 15, 2005
First Submission Date that Met QC Criteria
Jan 17, 2006
First Posted Date
Jan 19, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 11, 2010
Results First Submitted that Met QC Criteria
Jan 24, 2011
Results First Posted Date
Feb 21, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 24, 2011
Last Update Posted Date
Feb 21, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.
This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.
The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
diabetes
type 2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,091Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Insulin glargine
Active Comparator
Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
Drug: Insulin glargine
Lispro Low Mix
Experimental
Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Drug: Lispro Low Mix
Lispro Mid Mix prior Lispro Low Mix addendum
Experimental
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
Drug: Lispro Mid Mix
Lispro Low Mix prior Glargine addendum
Experimental
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase
MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%
Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
ADDENDUM: 24-Week Endpoint HbA1c
HbA1c at 24-week endpoint in Intensification Addendum of the trial.
Endpoint (Addendum) (24 weeks: Week 48)
Secondary Outcomes
Measure
Description
Time Frame
INITIATION: Change in HbA1c From Baseline to 24 Weeks
Baseline (Initiation) to Endpoint (LOCF, Week 24)
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
Endpoint (Initiation: Week 24)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have type 2 diabetes.
Must be at least 30 and less than 80 years of age at the time of Visit 1.
Must be on at least two oral antidiabetes medications for at least 90 days.
Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.
Exclusion Criteria:
Must not have used insulin on a regular basis in the last 12 months.
Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
Must not be pregnant or intend to get pregnant during course of the study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
30 Years
Maximum Age
79 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94(5):1689-94. doi: 10.1210/jc.2008-1940. Epub 2009 Mar 10.
Initiation: Glargine or Lispro LM - 24 weeks. Maintenance: Up to 2 more years treatment if HbA1c <=7.0 at 24 weeks. After Initiation, if HbA1c >7.0 after 24 weeks, instead of entering Maintenance, those from Lispro LM could receive Basal bolus or Mid Mix; glargine could receive Basal bolus or Lispro LM for 24 weeks in Intensification Addendum.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Insulin Glargine
Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
FG001
Lispro Low Mix
Periods
Title
Milestones
Reasons Not Completed
Initiation
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Drug: Insulin glargine
Drug: Lispro
Basal bolus prior Glargine addendum
Active Comparator
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Drug: Insulin glargine
Drug: Lispro
Lantus
Lispro Low Mix
Drug
Subcutaneous injection twice daily.
Lispro Low Mix
Lispro Low Mix prior Glargine addendum
Humalog Mix 75/25
Lispro Mid Mix
Drug
Lispro Mid Mix subcutaneous injection 3 times daily.
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.
Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Endpoint (Initiation: Week 24)
MAINTENANCE: HbA1c at Specified Visits and Endpoint
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Litchfield Park
Arizona
85340
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Little Rock
Arkansas
72205
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Anaheim
California
92805
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beverly Hills
California
90211
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Burlingame
California
94010
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Concord
California
94520
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fountain Valley
California
92708
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fresno
California
93720
United States
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Greenbrae
California
94904
United States
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La Jolla
California
92093
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Mesa
California
91942
United States
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Los Alamitos
California
90720
United States
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Los Angeles
California
90095
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Gatos
California
95032
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Norwalk
California
90650
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orange
California
92868
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Palm Springs
California
92262
United States
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Sacramento
California
95825
United States
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Salinas
California
93901
United States
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San Diego
California
92161
United States
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Spring Valley
California
91978
United States
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Vacaville
California
95687
United States
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Ventura
California
93003
United States
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Colorado Springs
Colorado
80917
United States
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Cromwell
Connecticut
06416
United States
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Trumbull
Connecticut
06611
United States
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Waterbury
Connecticut
06708
United States
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Deerfield Beach
Florida
33441
United States
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Gainesville
Florida
32605
United States
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Inverness
Florida
34452
United States
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Jacksonville
Florida
32208
United States
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Kissimmee
Florida
34741
United States
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Lake Worth
Florida
33461
United States
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Melbourne
Florida
32901
United States
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Miami
Florida
33125
United States
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New Port Richey
Florida
34655
United States
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Ocala
Florida
34471
United States
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Tampa
Florida
33603
United States
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West Palm Beach
Florida
33401
United States
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Winter Park
Florida
32789
United States
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Athens
Georgia
30606
United States
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Atlanta
Georgia
30342
United States
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Honolulu
Hawaii
96814
United States
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Kellogg
Idaho
83837
United States
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Belleville
Illinois
62220
United States
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Chicago
Illinois
60612
United States
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Gurnee
Illinois
60031
United States
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O'Fallon
Illinois
62269
United States
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Peoria
Illinois
61615
United States
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Fort Wayne
Indiana
46804
United States
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Indianapolis
Indiana
46256
United States
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Waterloo
Iowa
50702
United States
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Topeka
Kansas
66606
United States
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Bowling Green
Kentucky
42101
United States
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Madisonville
Kentucky
42431
United States
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Owensboro
Kentucky
42303
United States
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Baton Rouge
Louisiana
70808
United States
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Metairie
Louisiana
70006
United States
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Bangor
Maine
04401
United States
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Baltimore
Maryland
21204
United States
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Elkridge
Maryland
21075
United States
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Elkton
Maryland
21921
United States
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Reisterstown
Maryland
21136
United States
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Rockville
Maryland
20852
United States
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Towson
Maryland
21204
United States
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Haverhill
Massachusetts
01830
United States
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Waltham
Massachusetts
02453
United States
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Worcester
Massachusetts
01605
United States
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Bloomfield Hills
Michigan
48302
United States
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Troy
Michigan
48098
United States
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Bloomington
Minnesota
55420
United States
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Chesterfield
Missouri
63017
United States
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St Louis
Missouri
63104
United States
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Las Vegas
Nevada
89148
United States
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Reno
Nevada
89509
United States
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Nashua
New Hampshire
03063
United States
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Cherry Hill
New Jersey
08034
United States
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Flemington
New Jersey
08822
United States
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Hamilton
New Jersey
08610
United States
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Stratford
New Jersey
08084
United States
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Teaneck
New Jersey
07666
United States
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Toms River
New Jersey
08753
United States
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Cooperstown
New York
13326
United States
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Mamaroneck
New York
10543
United States
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Massapequa
New York
11758
United States
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New Hartford
New York
13413
United States
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New York
New York
10032
United States
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Syracuse
New York
13210
United States
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Westfield
New York
14787
United States
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Charlotte
North Carolina
28226
United States
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Greenville
North Carolina
27834
United States
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Huntersville
North Carolina
28078
United States
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Morehead City
North Carolina
28557
United States
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Morganton
North Carolina
28655
United States
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Tabor City
North Carolina
28463
United States
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Fargo
North Dakota
58104
United States
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Jamestown
North Dakota
58401
United States
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Akron
Ohio
44313
United States
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Cincinnati
Ohio
45224
United States
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Cleveland
Ohio
44122
United States
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Columbus
Ohio
43201
United States
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Dayton
Ohio
45439
United States
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Franklin
Ohio
45005
United States
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London
Ohio
43140
United States
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Oklahoma City
Oklahoma
73103
United States
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Bend
Oregon
97708
United States
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Eugene
Oregon
97401
United States
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Medford
Oregon
97504
United States
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Portland
Oregon
97210
United States
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Beaver
Pennsylvania
15009
United States
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Fleetwood
Pennsylvania
19522
United States
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Levittown
Pennsylvania
19056
United States
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Philadelphia
Pennsylvania
19146
United States
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Charleston
South Carolina
29412
United States
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Greenville
South Carolina
29605
United States
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Hartsville
South Carolina
29550
United States
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Johnson City
Tennessee
37604
United States
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Kingsport
Tennessee
37660
United States
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Memphis
Tennessee
38119
United States
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Abilene
Texas
79601
United States
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Dallas
Texas
75246
United States
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El Paso
Texas
79935
United States
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Houston
Texas
77005
United States
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Killeen
Texas
76543
United States
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Midland
Texas
79705
United States
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New Braunfels
Texas
78130
United States
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San Antonio
Texas
78229
United States
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Ogden
Utah
84403
United States
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Provo
Utah
84604
United States
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South Burlington
Vermont
05403
United States
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Bellingham
Washington
98226
United States
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Everett
Washington
98208
United States
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Olympia
Washington
98502
United States
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Renton
Washington
98057
United States
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Wenatchee
Washington
98801
United States
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Eau Claire
Wisconsin
54701
United States
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Marshfield
Wisconsin
54449
United States
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Buenos Aires
C1188AAF
Argentina
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Mar del Plata
7600
Argentina
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Pilar
B1629ODT
Argentina
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Kingswood Penrith
New South Wales
2747
Australia
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Elizabeth Vale
South Australia
5112
Australia
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Keswick
South Australia
5035
Australia
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Burnie
Tasmania
7320
Australia
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Box Hill
Victoria
3128
Australia
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Nedlands
Western Australia
6009
Australia
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Curitiba
80060-900
Brazil
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Porto Alegre
90035170
Brazil
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São Paulo
01221-020
Brazil
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Setor Oeste/Goiania
74043-110
Brazil
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Calgary
Alberta
T3B 0M3
Canada
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Red Deer
Alberta
T4N 6V7
Canada
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Winnipeg
Manitoba
R3C 0N2
Canada
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Petitcodiac
New Brunswick
E4Z 4R6
Canada
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Ajax
Ontario
L1S 7K8
Canada
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Mississauga
Ontario
L5M 2V8
Canada
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Niagara Falls
Ontario
L2G 5X7
Canada
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Laval
Quebec
H7T 2P5
Canada
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Sherbrooke
Quebec
J1G 5K2
Canada
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Athens
11526
Greece
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Nikaias - Piraeus
18454
Greece
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Thessaloniki
56429
Greece
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Eger
3300
Hungary
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Pécs
7623
Hungary
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Szekszárd
7100
Hungary
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Szentes
6600
Hungary
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Ahemdabad
380013
India
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Aligarh
202002
India
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Bangalore
560 054
India
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Coimbatore
India
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Hyderabaad
500033
India
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Karnal/Haryana
132 001
India
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Trivandrum
695029
India
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Amsterdam
1105 AZ
Netherlands
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Brunssum
6442 BE
Netherlands
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Emmen
7824 AA
Netherlands
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Hoogeveen
7909 AA
Netherlands
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Nijmegen
6500 HB
Netherlands
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Venlo
5912 BL
Netherlands
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Zwijndrecht
3331 LZ
Netherlands
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Bayamón
00959
Puerto Rico
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Carolina
00983
Puerto Rico
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Orcorvis
00720
Puerto Rico
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Ponce
00717-2075
Puerto Rico
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Rio Piedras
00936
Puerto Rico
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San Juan
00926
Puerto Rico
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Brasov
500326
Romania
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Bucharest
70266
Romania
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Cluj-Napoca
3400
Romania
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Târgu Mureş
540136
Romania
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Timișoara
1900
Romania
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Alzira
46600
Spain
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Dos Hermanas
41014
Spain
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Madrid
28040
Spain
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Málaga
29010
Spain
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Mosteles
28935
Spain
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Requena
46340
Spain
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Santander
39008
Spain
Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sci Technol. 2008 Sep;2(5):831-8. doi: 10.1177/193229680800200514.
Scheen AJ, Schmitt H, Jiang HH, Ivanyi T. Individualizing treatment of type 2 diabetes by targeting postprandial or fasting hyperglycaemia: Response to a basal vs a premixed insulin regimen by HbA1c quartiles and ethnicity. Diabetes Metab. 2015 Jun;41(3):216-22. doi: 10.1016/j.diabet.2015.03.002. Epub 2015 Apr 14.
Jovanovic L, Peters AL, Jiang HH, Hardin DS. Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes. Aging Clin Exp Res. 2014 Apr;26(2):115-21. doi: 10.1007/s40520-013-0140-8. Epub 2013 Oct 3.
Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11.
Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL. The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011 Feb;34(2):249-55. doi: 10.2337/dc10-1701.
Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther. 2010 May;32(5):896-908. doi: 10.1016/j.clinthera.2010.05.001.
Wolffenbuttel BH, Klaff LJ, Bhushan R, Fahrbach JL, Jiang H, Martin S. Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose-lowering agents. Diabet Med. 2009 Nov;26(11):1147-55. doi: 10.1111/j.1464-5491.2009.02824.x.
Buse JB, Wolffenbuttel BH, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL, Scism-Bacon JL, Martin SA. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1007-13. doi: 10.2337/dc08-2117. Epub 2009 Mar 31.
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
FG002
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
FG003
Lispro Low Mix Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
FG004
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
FG005
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
FG0001046 subjects
FG0011045 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000918 subjects
FG001900 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG000128 subjects
FG001145 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0006 subjects
FG00115 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG00042 subjects
FG00141 subjects
FG0020 subjects
FG0030 subjects
FG004
Entry Criteria Exclusion
FG0007 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0009 subjects
FG00110 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00035 subjects
FG00141 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG00015 subjects
FG00118 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG00013 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Discontinuation Oral Antihyperglycemics
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance
Type
Comment
Milestone Data
STARTED
FG000419 subjects100 left the study after initiation. 399 had HbA1c\>7% and enrolled in intensification addendum.
FG001473 subjects82 left the study after initiation. 345 had HbA1c\>7% and enrolled in intensification addendum.
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000188 subjects
FG001239 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG000231 subjects
FG001234 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG00032 subjects
FG00130 subjects
FG0020 subjects
FG003
Intensification Addendum
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG002174 subjects
FG003200 subjects
FG004171 subjects
FG005199 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG002151 subjects
FG003172 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00223 subjects
FG00328 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG00212 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Insulin Glargine
Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
BG001
Lispro LM
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment in the initiation phase. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
percent glycosylated hemoglobin
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Insulin Glargine
Insulin glargine for 24 weeks.
OG001
Lispro Low Mix
Lispro Low Mix (LM) for 24 weeks.
Units
Counts
Participants
OG000990
OG001986
Title
Denominators
Categories
Title
Measurements
OG0007.33± 1.07
OG0017.23± 1.08
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
P-value from ANCOVA, baseline value as covariate. Response = Treatment + Baseline + Country + thiazolidinedione (TZD) use + Sulfonylurea (sulfo) use.
0.005
95
No
Superiority or Other
Primary
MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%
Last observation carried forward method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Median
95% Confidence Interval
months
Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine
Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Primary
ADDENDUM: 24-Week Endpoint HbA1c
HbA1c at 24-week endpoint in Intensification Addendum of the trial.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: Week 24: 48 weeks.
Posted
Mean
Standard Deviation
percent glycosylated hemoglobin
Endpoint (Addendum) (24 weeks: Week 48)
ID
Title
Description
OG000
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro LM Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
INITIATION: Change in HbA1c From Baseline to 24 Weeks
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
percent glycosylated hemoglobin
Baseline (Initiation) to Endpoint (LOCF, Week 24)
ID
Title
Description
OG000
Insulin Glargine
Insulin glargine for 24 weeks.
OG001
Lispro Low Mix
Lispro Low Mix (LM) for 24 weeks.
Units
Counts
Participants
OG000
Secondary
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Number
percentage of participants
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Insulin Glargine
Insulin glargine for 24 weeks.
OG001
Lispro Low Mix
Lispro Low Mix (LM) for 24 weeks.
Units
Counts
Participants
OG000
Secondary
INITIATION: HbA1c
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
milligrams per 100 Milliliters (mg/dL)
Endpoint (LOCF) (Initiation: Week 24)
ID
Title
Description
OG000
Insulin Glargine
Insulin glargine for 24 weeks.
OG001
Lispro Low Mix
Lispro Low Mix (LM) for 24 weeks.
Units
Counts
Participants
OG000
Secondary
INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
micrograms per milliliter (ug/mL)
Baseline (Initiation), Endpoint (Week 24)
ID
Title
Description
OG000
Insulin Glargine
Insulin glargine for 24 weeks.
OG001
Lispro Low Mix
Lispro Low Mix (LM) for 24 weeks.
Units
Counts
Participants
OG000
Secondary
INITIATION: Incremental Change From Baseline in Body Weight
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Number
percentage of participants
Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
ID
Title
Description
OG000
Insulin Glargine
Insulin glargine for 24 weeks.
OG001
Lispro Low Mix
Lispro Low Mix (LM) for 24 weeks.
Units
Counts
Participants
Secondary
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
Episodes/participant/year
Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
ID
Title
Description
OG000
Insulin Glargine
Insulin glargine for 24 weeks.
OG001
Lispro Low Mix
Lispro Low Mix (LM) for 24 weeks.
Units
Counts
Participants
Secondary
INITIATION: Insulin Dose
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
years
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Number
participants
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
units on a scale
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
percent glycosylated hemoglobin
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Number
participants
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
micrograms per milliliter (ug/mL)
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Mean
Standard Deviation
milligrams per deciliter (mg/dL)
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
Posted
Number
participants
Endpoint (Initiation: Week 24)
ID
Title
Description
OG000
Met Goal
OG001
Did Not Meet Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
mg/dL
Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine
Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
Secondary
MAINTENANCE: Rate of Increase in HbA1c
Rate of increase: HbA1c change/time period (month).
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
HbA1c percent increase per month
Endpoint (LOCF) (Maintenance: up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine
Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
percentage of participants
Endpoint (LOCF) (Maintenance: up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine
Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Incremental Change From Baseline in Body Weight
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Body Weight
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Insulin Dose
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
percentage of participants
Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
ID
Title
Description
OG000
Insulin Glargine
Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Secondary
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
episodes/participant/year
Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
ID
Title
Description
OG000
Insulin Glargine
Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Secondary
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
ug/dL
Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine
Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
OG001
Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
years
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine Participants Who Maintained Goal
OG001
Insulin Glargine Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
years
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Lispro LM Participants Who Maintained Goal
OG001
Lispro LM Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
participants
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine Participants Who Maintained Goal
OG001
Insulin Glargine Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
participants
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Lispro LM Participants Who Maintained Goal
OG001
Lispro LM Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
percent glycosylated hemoglobin
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine Participants Who Maintained Goal
OG001
Insulin Glargine Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
percent glycosylated hemoglobin
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Lispro LM Participants Who Maintained Goal
OG001
Lispro LM Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
participants
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine Participants Who Maintained Goal
OG001
Insulin Glargine Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
participants
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Lispro LM Participants Who Maintained Goal
OG001
Lispro LM Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
participants
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine Participants Who Maintained Goal
OG001
Insulin Glargine Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Number
participants
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Lispro LM Participants Who Maintained Goal
OG001
Lispro LM Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
ug/mL
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine Participants Who Maintained Goal
OG001
Insulin Glargine Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
ug/ml
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Lispro LM Participants Who Maintained Goal
OG001
Lispro LM Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
mg/dL
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Insulin Glargine Participants Who Maintained Goal
OG001
Insulin Glargine Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
Posted
Mean
Standard Deviation
mg/dL
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ID
Title
Description
OG000
Lispro LM Participants Who Maintained Goal
OG001
Lispro LM Participants Who Did Not Maintain Goal
Units
Counts
Participants
OG000
Secondary
ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro LM Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Posted
Number
percent of participants
Endpoint (Addendum: 24 weeks [Week 48])
ID
Title
Description
OG000
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro LM Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: 7-point SMPG Profiles
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Posted
Mean
Standard Deviation
mg/dL
Endpoint (Addendum: 24 weeks [Week 48])
ID
Title
Description
OG000
Basal Bolus Prior Lispro LM Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: Incremental Change From Baseline in Body Weight
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: Body Weight
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: Insulin Dose
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Posted
Mean
Standard Deviation
episodes/participant/year
Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
ID
Title
Description
OG000
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro LM Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro Mid Mix Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Secondary
ADDENDUM: HbA1c at Specified Visits and Endpoint
Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
OG001
Lispro LM Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
OG002
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Time Frame
Not provided
Description
This trial did not collect non-serious adverse events other than hypoglycemia; results of which are included as secondary outcome measures.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Insulin Glargine Initiation
45
1,046
785
1,024
EG001
Lispro LM Initiation
65
1,045
826
1,026
EG002
Lispro Mid Mix Prior Lispro LM Addendum
5
174
96
171
EG003
Lispro LM Prior Glargine Addendum
10
200
111
198
EG004
Basal Bolus Prior Lispro LM Addendum
9
171
88
164
EG005
Basal Bolus Prior Glargine Addendum
11
199
92
192
EG006
Insulin Glargine Maintenance
48
419
394
419
EG007
Lispro LM Maintenance
48
473
463
473
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG0030 events0 affected200 at risk
EG0040 events0 affected171 at risk
EG0050 events0 affected199 at risk
EG0062 events1 affected419 at risk
EG0071 events1 affected473 at risk
Normochromic normocytic anaemia
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0021 events1 affected174 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0014 events4 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0021 events1 affected174 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0004 events4 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0013 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0013 events3 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Intracardiac thrombus
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0013 events3 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Ventricular dysfunction
Cardiac disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cataract
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Epiploic appendagitis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hernial eventration
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Rectal polyp
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Thrombosis mesenteric vessel
Gastrointestinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Chest discomfort
General disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Chest pain
General disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Exercise tolerance decreased
General disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Fatigue
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gait disturbance
General disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 12.
Systematic Assessment
EG0002 events2 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0021 events1 affected174 at risk
EG003
Corneal abscess
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0002 events2 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Encephalitis viral
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gangrene
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Localised infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Nail bed infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pilonidal cyst
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Postoperative infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Renal abscess
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Sepsis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Septic shock
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0002 events2 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Viral infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Wound infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Drug exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 12.
Systematic Assessment
EG0002 events2 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Operative haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Weight increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0012 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Diabetic foot
Metabolism and nutrition disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0021 events1 affected174 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0013 events3 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Benign female reproductive tract neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Tongue neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Carotid artery occlusion
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0014 events4 affected1,045 at risk
EG0021 events1 affected174 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Facial palsy
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Hypoglycaemic coma
Nervous system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Migraine
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Syncope
Nervous system disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Vertebrobasilar insufficiency
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Adjustment disorder with depressed mood
Psychiatric disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Catatonia
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Bladder obstruction
Renal and urinary disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0012 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0013 events2 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Stevens-johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Femoral artery occlusion
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0011 events1 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Shock
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Vascular pseudoaneurysm
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 12.
Systematic Assessment
EG0000 events0 affected1,046 at risk
EG0010 events0 affected1,045 at risk
EG0020 events0 affected174 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypoglycemia
Metabolism and nutrition disorders
Systematic Assessment
EG0009,994 events785 affected1,024 at risk
EG00113,164 events826 affected1,026 at risk
EG002905 events96 affected171 at risk
EG003927 events111 affected198 at risk
EG004869 events88 affected164 at risk
EG005785 events92 affected192 at risk
EG00616,861 events394 affected419 at risk
EG00722,562 events463 affected473 at risk
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D003924
Diabetes Mellitus, Type 2
D003920
Diabetes Mellitus
Ancestor Terms
ID
Term
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069036
Insulin Glargine
C482266
insulin lispro, isophane insulin lispro drug combination (25:75)
D061268
Insulin Lispro
Ancestor Terms
ID
Term
D049528
Insulin, Long-Acting
D061385
Insulins
D010187
Pancreatic Hormones
D036361
Peptide Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D061266
Insulin, Short-Acting
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Discontinuation Antihyperglycemic Drugs
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0004 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Death
FG0004 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG00017 subjects
FG00113 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Entry Criteria Exclusion
FG0001 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Protocol Violation
FG00016 subjects
FG00124 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG00018 subjects
FG00118 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Physician Decision
FG0009 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Sponsor Decision
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
HbA1c>7.5%
FG000123 subjects
FG001126 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
142 subjects
FG005162 subjects
29 subjects
FG00537 subjects
14 subjects
FG0049 subjects
FG00518 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0036 subjects
FG0047 subjects
FG0057 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0056 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG0041 subjects
FG0053 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
FG0043 subjects
FG0052 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
Entry Criteria Exclusion
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
987
Male
BG000552
BG001552
BG0021104
1319
African Descent
Title
Measurements
BG00070
BG00162
BG002132
East/Southeast Asian
Title
Measurements
BG00027
BG00118
BG00245
Hispanic
Title
Measurements
BG000116
BG001136
BG002252
Other
Title
Measurements
BG00029
BG00139
BG00268
Western Asian
Title
Measurements
BG000136
BG001139
BG002275
1022
Hungary
Title
Measurements
BG00024
BG00126
BG00250
Greece
Title
Measurements
BG00025
BG00125
BG00250
Canada
Title
Measurements
BG00060
BG00160
BG002120
Argentina
Title
Measurements
BG00098
BG00195
BG002193
Brazil
Title
Measurements
BG00045
BG00146
BG00291
Spain
Title
Measurements
BG00047
BG00149
BG00296
Romania
Title
Measurements
BG00029
BG00128
BG00257
Australia
Title
Measurements
BG00048
BG00148
BG00296
Netherlands
Title
Measurements
BG00030
BG00127
BG00257
India
Title
Measurements
BG000131
BG001128
BG002259
88.53
± 20.87
31.68
± 5.98
9.51
± 6.11
9.04
± 1.26
4.99
± 4.09
200.13
± 56.14
240.82
± 59.61
217.08
± 55.48
194.53
± 54.20
418
OG001470
Title
Denominators
Categories
Title
Measurements
OG00014.40(13.40 to 16.83)
OG00116.80(14.03 to 19.67)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Stratified by country, thiazolidinedione (TZD) use, sulfo use.
0.040
95
No
Superiority or Other
OG003
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000160
OG001187
OG002159
OG003176
Title
Denominators
Categories
Title
Measurements
OG0008.19± 1.26
OG0018.03± 1.15
OG0028.16± 1.43
OG0038.14± 1.53
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.271
95
No
Superiority or Other
OG000
OG002
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.990
95
No
Superiority or Other
977
OG001962
Title
Denominators
Categories
Title
Measurements
OG000-1.68± 1.27
OG001-1.83± 1.27
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use + Sulfo use.
0.005
95
No
Superiority or Other
990
OG001986
Title
Denominators
Categories
<=7.0%
Title
Measurements
OG00045.8
OG00152.5
<7.0%
Title
Measurements
OG00040.3
OG00147.5
<=6.5%
Title
Measurements
OG00022.2
OG00124.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.
0.002
P-value for <=7.0%.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.
<0.001
P-value is for <7.0%.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.
0.174
P-value is for <=6.5%.
95
No
Superiority or Other
1030
OG0011017
Title
Denominators
Categories
Baseline (n=1030,1017)
Title
Measurements
OG0009.02± 1.24
OG0019.06± 1.29
Week 12 (n=952,953)
Title
Measurements
OG0007.42± 0.95
OG0017.27± 0.99
Week 24 (n=922,911)
Title
Measurements
OG0007.28± 1.06
OG0017.19± 1.03
Endpoint (LOCF) (n=990,986)
Title
Measurements
OG0007.33± 1.07
OG0017.23± 1.08
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use, and sulfo use in model.
0.416
P-value for baseline.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use + sulfo use.
<0.001
P-value for Week 12.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use + sulfo use.
0.003
P-value for Week 24.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use + sulfo use.
Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.
0.370
P-value is for Overall hypoglycemic episodes endpoint.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Controlling for country, TZD use, and sulfo use.
0.006
P-Value for Overall hypoglycemia episodes.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.
0.397
P-value is for Nocturnal episodes endpoint.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Controlling for country, TZD use, and sulfo use.
0.253
P-value is for Nocturnal episodes overall.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Controlling for country, TZD use, and sulfo use.
0.893
P-value is for Severe episodes endpoint.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.
0.391
P-value is for Severe episodes overall.
95
No
Superiority or Other
Units
Counts
Participants
OG000415
OG001471
Title
Denominators
Categories
Hypoglycemia episodes Endpoint
Title
Measurements
OG00016.41± 34.78
OG00118.56± 35.50
Hypoglycemia episodes Overall
Title
Measurements
OG00021.80± 26.77
OG00126.08± 31.69
Nocturnal episodes Endpoint
Title
Measurements
OG0007.70± 19.36
OG0015.86± 15.96
Nocturnal episodes Overall
Title
Measurements
OG0009.77± 15.01
OG0018.02± 13.49
Severe episodes Endpoint
Title
Measurements
OG0000.23± 4.43
OG0010.03± 0.46
Severe episodes Overall
Title
Measurements
OG0000.12± 2.12
OG0010.03± 0.21
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.497
P-value for Hypoglycemia episodes Endpoint.
95
No
Superiority or Other
OG000
OG001
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.071
P-value is for Hypoglycemia episodes Overall.
95
No
Superiority or Other
OG000
OG001
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.065
P-value is for Nocturnal episodes Endpoint.
95
No
Superiority or Other
OG000
OG001
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.021
P-value is for Nocturnal episodes Overall.
95
No
Superiority or Other
OG000
OG001
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.200
P-value is for Severe episodes Endpoint.
95
No
Superiority or Other
OG000
OG001
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.208
P-value is for Severe episodes Overall.
95
No
Superiority or Other
372
OG001428
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.66± 4.34
OG0015.87± 4.51
Endpoint
Title
Measurements
OG00010.48± 6.26
OG00111.71± 6.44
Change
Title
Measurements
OG0004.82± 5.28
OG0015.84± 5.19
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model with treatment, baseline, country, TZD use and sulfo use.
0.004
P-value is for Change.
95
No
Superiority or Other
415
OG001469
Title
Denominators
Categories
Baseline at Week 0 (n=415,464)
Title
Measurements
OG0008.59± 1.08
OG0018.69± 1.16
Change from baseline to endpoint (n=409,462)
Title
Measurements
OG000-1.38± 1.18
OG001-1.59± 1.22
Change Week 24 to Week 120 endpoint (n=412,469)
Title
Measurements
OG0000.71± 0.11
OG0010.61± 0.75
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA used with treatment, country, TZD use and Sulfo use in the model.
0.204
P-value is for Baseline at Week 0.
95
No
Superiority or Other
OG000
OG001
ANCOVA
ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.
0.017
P-Value is for Change from baseline to endpoint.
95
No
Superiority or Other
OG000
OG001
ANCOVA
ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.
0.020
P-value is for Change Week 24 to Week 120 endpoint.
95
No
Superiority or Other
147
OG001272
Title
Denominators
Categories
Title
Measurements
OG0008.44± 4.92
OG0019.70± 6.12
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.036
95
No
Superiority or Other
202
OG001271
Title
Denominators
Categories
Title
Measurements
OG0009.42± 6.24
OG0019.87± 6.38
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.708
95
No
Superiority or Other
147
OG001272
Title
Denominators
Categories
Less than 10 years
Title
Measurements
OG00096
OG001152
10 years to less than 20 years
Title
Measurements
OG00045
OG00194
20 or more years
Title
Measurements
OG0006
OG00126
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.
0.028
95
No
Superiority or Other
202
OG001271
Title
Denominators
Categories
<10 years
Title
Measurements
OG000112
OG001148
10 to <20 years
Title
Measurements
OG00078
OG00197
>=20 years
Title
Measurements
OG00012
OG00126
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by country, TZD use, and sulfo use.
0.738
95
No
Superiority or Other
143
OG001270
Title
Denominators
Categories
Title
Measurements
OG0008.27± 0.94
OG0018.77± 1.11
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
<0.001
95
No
Superiority or Other
198
OG001268
Title
Denominators
Categories
Title
Measurements
OG0008.54± 1.13
OG0018.80± 1.17
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.043
95
No
Superiority or Other
143
OG001270
Title
Denominators
Categories
Less than 8.5% HbA1c
Title
Measurements
OG00097
OG001121
>=8.5% HbA1c
Title
Measurements
OG00046
OG001149
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.
<0.001
95
No
Superiority or Other
198
OG001268
Title
Denominators
Categories
Less than 8.5
Title
Measurements
OG000110
OG001121
8.5 or more
Title
Measurements
OG00088
OG001147
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.
0.032
95
No
Superiority or Other
144
OG001269
Title
Denominators
Categories
Sulfonylurea/TZD
Title
Measurements
OG00016
OG00113
Sulfonylurea/metformin
Title
Measurements
OG00073
OG001175
Metformin/TZD
Title
Measurements
OG00022
OG00122
Sulfonylurea/metformin/TZD
Title
Measurements
OG00033
OG00159
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.037
P-value is for Sulfonylurea/TZD.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.025
P-value is for Sulfonylurea/metformin.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.132
P-value is for Metformin/TZD.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.849
P-value is for Sulfonylurea/metformin/TZD.
95
No
Superiority or Other
199
OG001270
Title
Denominators
Categories
Sulfonylurea/TZD
Title
Measurements
OG00014
OG0015
Sulfonylurea/metformin
Title
Measurements
OG000115
OG001185
Metformin/TZD
Title
Measurements
OG00025
OG00121
Sulfonylurea/metformin/TZD
Title
Measurements
OG00045
OG00159
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.006
P-value is for Sulfonylurea/TZD
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.048
P-value is for Sulfonylurea/metformin.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.258
P-value is for Metformin/TZD.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by country only.
0.848
P-value is for Sulfonylurea/metformin/TZD.
95
No
Superiority or Other
146
OG001271
Title
Denominators
Categories
Title
Measurements
OG0006.29± 4.60
OG0015.39± 4.22
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.004
95
No
Superiority or Other
199
OG001265
Title
Denominators
Categories
Title
Measurements
OG0005.93± 4.17
OG0015.73± 4.64
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.553
95
No
Superiority or Other
141
OG001264
Title
Denominators
Categories
Mean of post meals blood glucose (n=141,261)
Title
Measurements
OG000219.28± 51.23
OG001233.51± 54.90
Average of all blood glucose (n=141,264)
Title
Measurements
OG000200.60± 48.07
OG001210.44± 50.63
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.010
P-value is for Mean of all post meals blood glucose.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.035
P-value is for Average of all blood glucose.
95
No
Superiority or Other
195
OG001262
Title
Denominators
Categories
Mean of post meals blood glucose
Title
Measurements
OG000223.98± 52.54
OG001231.66± 54.30
Average of all blood glucose
Title
Measurements
OG000201.42± 48.42
OG001207.96± 49.09
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.516
P-value is for Mean of post-meals blood glucose.
95
No
Superiority or Other
OG000
OG001
ANOVA
From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.
0.425
P-value is for Average of all blood glucose.
95
No
Superiority or Other
OG003
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000174
OG001200
OG002171
OG003199
Title
Denominators
Categories
Baseline (n=174,200,171,199)
Title
Measurements
OG0008.01± 0.93
OG0018.03± 0.95
OG0028.00± 0.92
OG0037.98± 0.95
Endpoint (n=160,187,159,176)
Title
Measurements
OG0000.19± 1.12
OG0010.04± 1.06
OG0020.19± 1.16
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANOVA
ANOVA with treatment, country, TZD use in model.
0.770
P-value is for Baseline.
95
No
Superiority or Other
OG000
OG002
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.990
P-value is for Endpoint.
95
No
Superiority or Other
OG001
OG003
ANOVA
ANOVA with treatment, country, TZD use in model.
0.552
P-value is for Baseline.
95
No
Superiority or Other
OG001
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.271
P-value is for Endpoint.
95
No
Superiority or Other
OG003
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000176
OG001187
OG002159
OG003176
Title
Denominators
Categories
<=7.0%
Title
Measurements
OG00012.5
OG00116.0
OG00222.0
OG00318.2
<7.0%
Title
Measurements
OG0008.8
OG00113.9
OG00217.6
OG003
<=6.5%
Title
Measurements
OG0004.4
OG0013.7
OG0025.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Fisher Exact
0.027
P-value is for <=7.0%.
95
No
Superiority or Other
OG000
OG002
Fisher Exact
0.021
P-value is for <7.0%.
95
No
Superiority or Other
OG000
OG002
Fisher Exact
0.799
P-value is for <=6.5%.
95
No
Superiority or Other
OG001
OG003
Fisher Exact
0.676
P-value is for <=7.0%.
95
No
Superiority or Other
OG001
OG003
Fisher Exact
1.000
P-value is for <7.0%.
95
No
Superiority or Other
OG001
OG003
Fisher Exact
1.000
P-value is for <=6.5%.
95
No
Superiority or Other
OG003
Lispro Low Mix Prior Glargine Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000152
OG001161
OG002183
OG003187
Title
Denominators
Categories
Mean fast blood glucose (BG) (n=135,150,161,178)
Title
Measurements
OG000145.33± 35.23
OG001151.15± 37.31
OG002126.22± 39.00
OG003139.45± 34.92
AM 2-hour postprandial (PP) BG (n=135,149,160,176)
Title
Measurements
OG000168.71± 44.90
OG001170.36± 50.25
OG002170.14± 49.27
OG003
Midday premeal blood glucose (n=135,150,161,177)
Title
Measurements
OG000144.08± 43.93
OG001145.89± 42.61
OG002144.61± 41.39
OG003
Midday 2-hour (hr) PP BG (n=135,149,160,176))
Title
Measurements
OG000165.24± 46.46
OG001164.13± 42.17
OG002167.45± 48.27
OG003
PM premeal blood glucose (n=135,150,161,178)
Title
Measurements
OG000153.62± 41.82
OG001151.96± 41.66
OG002157.15± 54.22
OG003
PM 2-hour postprandial BG (n=134,150,161,178)
Title
Measurements
OG000171.51± 44.42
OG001172.98± 48.01
OG002175.34± 53.17
OG003
3 AM blood glucose (n=132,146,153,171)
Title
Measurements
OG000146.50± 40.09
OG001146.30± 41.36
OG002147.14± 39.99
OG003
AM 2-hour BG excursion (n=135,149,160,176)
Title
Measurements
OG00023.30± 39.14
OG00118.97± 46.88
OG00224.35± 38.44
OG003
Midday 2-hour BG excursion (n=135,148,160,176)
Title
Measurements
OG00020.71± 43.35
OG00118.97± 41.40
OG00223.30± 37.21
OG003
PM 2-hour BG excursion (n=134,150,161,178)
Title
Measurements
OG00017.88± 38.16
OG00121.14± 42.48
OG00218.58± 41.86
OG003
Mean all mealtime excursions (n=135,150,161,178)
Title
Measurements
OG00020.61± 28.41
OG00119.64± 27.87
OG00221.82± 26.09
OG003
Mean all 2-hour PP BG (n=135,150,161,178)
Title
Measurements
OG000168.55± 38.92
OG001169.14± 39.27
OG002170.95± 42.89
OG003
Mean all premeal blood glucose (n=135,150,161,178)
Title
Measurements
OG000147.68± 32.85
OG001149.67± 33.20
OG002149.04± 38.35
OG003
Mean combined AM/PM 2hr PP BG (n=135,150,161,178)
Title
Measurements
OG000170.04± 39.98
OG001171.65± 43.23
OG002172.73± 45.15
OG003
Mean AM/PM 2hr BG excursion (n=135,150,161,178)
Title
Measurements
OG00020.74± 30.40
OG00120.06± 34.62
OG00221.42± 32.09
OG003
Mean all BG values (n=135,150,161,178)
Title
Measurements
OG000156.41± 33.04
OG001157.52± 32.67
OG002158.33± 37.89
OG003
Baseline mean all premeals BG (n=152,161,183,187)
Title
Measurements
OG000149.91± 38.96
OG001149.50± 34.82
OG002146.64± 39.89
OG003
Baseline mean of postmeal BG (n=152,161,182,187)
Title
Measurements
OG000183.82± 45.13
OG001181.18± 43.49
OG002186.19± 46.23
OG003
Baseline average of all BG (n=152,161,183,187)
Title
Measurements
OG000164.02± 39.20
OG001162.18± 35.22
OG002163.19± 40.08
OG003
Baseline fasting glucose (n=152,161,183,187)
Title
Measurements
OG000147.93± 39.46
OG001143.99± 34.91
OG002131.54± 42.16
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.241
P-value is for Mean fast blood glucose (BG).
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.305
P-value is for AM 2-hour postprandial (PP) BG.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.842
P-value is for Midday premeal blood glucose.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.917
P-value is for Midday 2-hour (hr) PP BG.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.648
P-value is for PM premeal blood glucose.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.613
P-value is for PM 2-hour postprandial BG.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.813
P-value is for 3 AM blood glucose.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.953
P-value is for AM 2-hour BG excursion.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.933
P-value is for Midday 2-hour BG excursion.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.348
P-value is for PM 2-hour BG excursion.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.625
P-value is for Mean all mealtime excursions.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.573
P-value is for Mean all 2-hour PP BG.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.711
P-value is for Mean all premeal blood glucose.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.372
P-value is for Mean combined AM/PM 2hr PP BG.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.516
P-value is for Mean AM/PM 2hr BG excursion.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.639
P-value is for Mean all BG values.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.131
P-value is for Mean fast blood glucose (BG).
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.530
P-value is for AM 2-hour postprandial (PP) BG.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.578
P-value is for Midday premeal blood glucose.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.004
P-value is for Midday 2-hour (hr) PP BG.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.951
P-value is for PM premeal blood glucose.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.580
P-value is for PM 2-hour postprandial BG.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.071
P-value is for 3 AM blood glucose.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.081
P-value is for AM 2-hour BG excursion.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
<0.001
P-value is for Midday 2-hour BG excursion.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.542
P-value is for PM 2-hour BG excursion.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.003
P-value is for Mean all mealtime excursions.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.105
P-value is for Mean all 2-hour PP BG.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.487
P-value is for Mean all premeal blood glucose.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.491
P-value is for Mean combined AM/PM 2hr PP BG.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.127
P-value is for Mean AM/PM 2hr BG excursion.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.861
P-value is for Mean all BG values.
95
No
Superiority or Other
OG003
Lispro Low Mix Prior Glargine Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000170
OG001173
OG002198
OG003200
Title
Denominators
Categories
Baseline (n=170,173,198,200)
Title
Measurements
OG00091.85± 23.41
OG00193.63± 24.21
OG00289.25± 21.62
OG00390.09± 23.45
Week 6 change (n=161,162,183,193)
Title
Measurements
OG0000.38± 2.78
OG0010.28± 1.76
OG0020.32± 2.15
OG003
Week 12 change (n=150,158,173,187)
Title
Measurements
OG0000.43± 2.61
OG0010.54± 2.36
OG0020.27± 3.31
OG003
Week 24 change (n=144,151,163,176)
Title
Measurements
OG0000.77± 3.01
OG0010.73± 2.85
OG0021.03± 3.24
OG003
Endpoint change (n=163,169,191,198)
Title
Measurements
OG0000.85± 3.46
OG0010.55± 2.85
OG0020.86± 3.41
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in model.
0.745
P-value is for Baseline.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in model.
0.467
P-value is for Baseline.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.575
P-value is for Week 6.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.726
P-value is for Week 12.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.978
P-value is for Week 24.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.345
P-value is for Endpoint.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.166
P-value is for Week 6.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.064
P-value is for Week 12.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.199
P-value is for Week 24.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.098
P-value is for Endpoint.
95
No
Superiority or Other
OG003
Lispro Low Mix Prior Glargine Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000170
OG001173
OG002198
OG003200
Title
Denominators
Categories
Baseline (n=170,173,198,200)
Title
Measurements
OG00091.85± 23.41
OG00193.63± 24.21
OG00289.25± 21.62
OG00390.09± 23.45
Week 6 (n=162,163,184,193)
Title
Measurements
OG00091.53± 23.33
OG00193.71± 24.82
OG00289.66± 21.97
OG003
Week 12 (n=151,158,174,187)
Title
Measurements
OG00091.59± 22.88
OG00194.60± 25.08
OG00289.62± 22.04
OG003
Week 24 (n=145,151,164,176)
Title
Measurements
OG00091.92± 23.32
OG00194.18± 24.99
OG00289.80± 21.95
OG003
Endpoint (n=164,170,192,198)
Title
Measurements
OG00092.40± 23.67
OG00194.09± 24.65
OG00290.09± 21.95
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with treatment, country, and TZD use in model.
0.467
P-value is for Baseline.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.575
P-value is for Week 6.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.726
P-value is for Week 12.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.978
P-value is for Week 24.
95
No
Superiority or Other
OG000
OG001
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.345
P-value is for Endpoint.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, and TZD use in model.
0.745
P-value is for Baseline.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.166
P-value is for Week 6.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.064
P-value is for Week 12.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.199
P-value is for Week 24.
95
No
Superiority or Other
OG002
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.098
P-value is for Endpoint.
95
No
Superiority or Other
OG003
Lispro Low Mix Prior Glargine Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000171
OG001174
OG002199
OG003200
Title
Denominators
Categories
Baseline (n=171,174,199,200)
Title
Measurements
OG0000.55± 0.26
OG0010.55± 0.25
OG0020.46± 0.27
OG0030.46± 0.24
Week 1 (n=152,158,183,183)
Title
Measurements
OG0000.58± 0.26
OG0010.57± 0.25
OG0020.49± 0.27
OG003
Week 2 (n=147,159,180,187)
Title
Measurements
OG0000.63± 0.29
OG0010.59± 0.26
OG0020.54± 0.29
OG003
Week 3 (n=149,158,179,184)
Title
Measurements
OG0000.65± 0.28
OG0010.64± 0.26
OG0020.57± 0.28
OG003
Week 4 (n=145,157,178,178)
Title
Measurements
OG0000.69± 0.29
OG0010.67± 0.27
OG0020.63± 0.34
OG003
Week 5 (n=148,153,172,173)
Title
Measurements
OG0000.73± 0.29
OG0010.70± 0.28
OG0020.65± 0.34
OG003
Week 6 (n=162,168,190,196)
Title
Measurements
OG0000.73± 0.29
OG0010.72± 0.29
OG0020.68± 0.37
OG003
Week 8 (n=139,154,164,174)
Title
Measurements
OG0000.76± 0.29
OG0010.75± 0.32
OG0020.71± 0.38
OG003
Week 10 (n=141,152,158,174)
Title
Measurements
OG0000.78± 0.31
OG0010.77± 0.32
OG0020.76± 0.43
OG003
Week 12 (n=152,161,177,190)
Title
Measurements
OG0000.80± 0.33
OG0010.79± 0.33
OG0020.77± 0.42
OG003
Week 24 (n=147,151,166,179)
Title
Measurements
OG0000.82± 0.35
OG0010.80± 0.35
OG0020.79± 0.45
OG003
Endpoint (n=165,170,199,200)
Title
Measurements
OG0000.81± 0.35
OG0010.79± 0.35
OG0020.77± 0.43
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.837
P-value is for Week 1.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.205
P-value is for Week 2.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.704
P-value is for Week 3.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.610
P-value is for Week 4.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.352
P-value is for Week 5.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.636
P-value is for Week 6.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.880
P-value is for Week 8.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.904
P-value is for Week 10.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.859
P-value is for Week 12.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.654
P-value is for Week 24.
95
No
Superiority or Other
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.566
P-value is for Endpoint.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.926
P-value is for Week 1.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.902
P-value is for Week 2.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.766
P-value is for Week 3.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.449
P-value is for Week 4.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.797
P-value is for Week 5.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.438
P-value is for Week 6.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.602
P-value is for Week 8.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.493
P-value is for Week 10.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.335
P-value is for Week 12.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.398
P-value is for Week 24.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in the model.
0.903
P-value is for Endpoint.
95
No
Superiority or Other
OG002
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG003
Lispro Low Mix Prior Glargine Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000164
OG001171
OG002192
OG003198
Title
Denominators
Categories
Hypoglycemia episodes endpoint
Title
Measurements
OG00040.9
OG00141.5
OG00234.9
OG00340.9
Overall hypoglycemia episodes
Title
Measurements
OG00053.7
OG00156.1
OG00247.9
OG003
Severe episodes endpoint
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Severe episodes overall
Title
Measurements
OG0000.0
OG0011.2
OG0020.0
OG003
Nocturnal episodes endpoint
Title
Measurements
OG00025.0
OG00120.5
OG00219.3
OG003
Nocturnal episodes overall
Title
Measurements
OG00031.1
OG00131.0
OG00227.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.953
P-value is for Hypoglycemia episodes endpoint.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.953
P-value is for Overall hypoglycemia episodes.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.188
P-value is for Severe episodes overall.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.226
P-value is for Nocturnal episodes endpoint.
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.855
P-value is for Nocturnal episodes overall.
95
No
Superiority or Other
OG002
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.250
P-value is for Hypoglycemia episodes at endpoint.
95
No
Superiority or Other
OG002
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.123
P-value is for Overall hypoglycemia episodes.
95
No
Superiority or Other
OG002
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.166
P-value is for Severe episodes overall.
95
No
Superiority or Other
OG002
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.273
P-value is for Nocturnal episodes endpoint.
95
No
Superiority or Other
OG002
OG003
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel statistic controlling for country and TZD use.
0.039
P-value is for Nocturnal episodes overall.
95
No
Superiority or Other
OG002
Basal Bolus Prior Lispro Low Mix Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
OG003
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000171
OG001198
OG002164
OG003192
Title
Denominators
Categories
Hypoglycemia episodes Endpoint
Title
Measurements
OG00011.10± 20.36
OG00110.11± 21.84
OG00212.11± 28.20
OG00311.18± 44.80
Hypoglycemia episodes Overall
Title
Measurements
OG00011.54± 18.70
OG00110.73± 18.06
OG00211.39± 22.75
OG003
Nocturnal episodes Endpoint
Title
Measurements
OG0002.46± 8.14
OG0012.51± 7.03
OG0022.37± 6.10
OG003
Nocturnal episodes Overall
Title
Measurements
OG0002.47± 6.29
OG0013.14± 6.58
OG0022.09± 5.25
OG003
Severe episodes Endpoint
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.00± 0.00
OG003
Severe episodes Overall
Title
Measurements
OG0000.02± 0.23
OG0010.02± 0.21
OG0020.00± 0.00
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.623
P-value is for Hypoglycemia episodes Endpoint.
95
No
Superiority or Other
OG000
OG002
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.949
P-value is for Hypoglycemic episodes Overall.
95
No
Superiority or Other
OG001
OG003
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.730
P-value is for Hypoglycemia episodes Endpoint.
95
No
Superiority or Other
OG001
OG003
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.445
P-value is for Hypoglycemia episodes Overall.
95
No
Superiority or Other
OG000
OG002
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.949
P-value is for Nocturnal episodes Endpoint.
95
No
Superiority or Other
OG000
OG002
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.590
P-value is for Nocturnal episodes Overall.
95
No
Superiority or Other
OG001
OG003
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.657
P-value is for Nocturnal episodes Endpoint.
95
No
Superiority or Other
OG001
OG003
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.108
P-value is for Nocturnal episodes Overall.
95
No
Superiority or Other
OG001
OG003
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.161
P-value is for Severe episodes Overall.
95
No
Superiority or Other
OG000
OG002
ANOVA
Response = Treatment + Country + TZD use + Sulfo use.
0.178
P-value is for Severe episodes Overall.
95
No
Superiority or Other
OG003
Lispro Low Mix Prior Glargine Addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000166
OG001172
OG002197
OG003199
Title
Denominators
Categories
Baseline (n=166,172,197,199)
Title
Measurements
OG0007.84± 5.27
OG0017.77± 5.01
OG0027.31± 4.99
OG0037.37± 5.07
Endpoint (n=142,150,165,171)
Title
Measurements
OG0008.18± 6.27
OG0017.73± 5.74
OG0028.43± 6.17
OG003
Change (n=142,150,165,171)
Title
Measurements
OG0000.26± 4.40
OG001-0.18± 4.91
OG0020.90± 4.31
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
ANOVA with treatment, country, TZD use in model.
0.917
P-value is for Baseline.
95
No
Superiority or Other
OG002
OG003
ANOVA
ANOVA with treatment, country, TZD use in model.
0.754
P-value for Baseline.
95
No
Superiority or Other
OG000
OG001
ANCOVA
ANCOVA model with treatment, baseline, country, and TZD use.
0.420
P-value is for Change.
95
No
Superiority or Other
OG002
OG003
ANCOVA
ANCOVA model with treatment, baseline, country, and TZD use.
0.514
P-value for Change.
95
No
Superiority or Other
OG003
Basal Bolus Prior Glargine Addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
Units
Counts
Participants
OG000174
OG001200
OG002171
OG003199
Title
Denominators
Categories
Baseline (n=174,200,171,199)
Title
Measurements
OG0008.01± 0.93
OG0018.03± 0.95
OG0028.00± 0.92
OG0037.98± 0.95
Week 12 (n=150,175,151,161)
Title
Measurements
OG0008.11± 1.06
OG0018.07± 1.20
OG0028.13± 1.26
OG003
Week 24 (n=145,171,144,159)
Title
Measurements
OG0008.19± 1.27
OG0018.05± 1.18
OG0028.19± 1.47
OG003
Endpoint (n=160, 187,159,176)
Title
Measurements
OG0008.19± 1.26
OG0018.03± 1.15
OG0028.16± 1.43
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANOVA
ANOVA with treatment, country, TZD use in model.
0.770
P-value is for Baseline.
95
No
Superiority or Other
OG000
OG002
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.566
P-value is for Week 12.
95
No
Superiority or Other
OG000
OG002
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.812
P-value is for Week 24.
95
No
Superiority or Other
OG000
OG002
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.990
P-value is for Endpoint.
95
No
Superiority or Other
OG001
OG003
ANOVA
ANOVA with treatment, country, TZD use in model.
0.552
P-value is for Baseline.
95
No
Superiority or Other
OG001
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.179
P-value is for Week 12.
95
No
Superiority or Other
OG001
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.
0.377
P-value is for Week 24.
95
No
Superiority or Other
OG001
OG003
ANCOVA
Response = Treatment + Baseline + Country + TZD use.