A Study of LY2189265 in Japanese Participants With Type 2... | NCT01468181 | Trialant
NCT01468181
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jan 29, 2015Estimated
Enrollment
394Actual
Phase
Phase 3
Conditions
Type 2 Diabetes Mellitus
Interventions
LY2189265
Sulfonylureas (SU)
Biguanides (BG)
alpha-glucosidase inhibitor (a-GI)
Thiazolidinedione (TZD)
Glinides
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01468181
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
13991
Secondary IDs
ID
Type
Description
Link
H9X-JE-GBDQ
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
Official Title
A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2015
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
Nov 2011
Primary Completion Date
Dec 2013Actual
Completion Date
Dec 2013Actual
First Submitted Date
Nov 7, 2011
First Submission Date that Met QC Criteria
Nov 7, 2011
First Posted Date
Nov 9, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 8, 2014
Results First Submitted that Met QC Criteria
Dec 8, 2014
Results First Posted Date
Dec 16, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 14, 2014
Certification/Extension First Submitted that Passed QC Review
Apr 14, 2014
Certification/Extension First Posted Date
May 7, 2014Estimated
Last Update Submitted Date
Jan 16, 2015
Last Update Posted Date
Jan 29, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus
Oral antihyperglycemic medications
Long-Term Safety
GLP 1
Glucagon like peptide 1
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
394Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2189265 + Sulfonylureas (SU)
Experimental
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
Drug: LY2189265
Drug: Sulfonylureas (SU)
LY2189265 + Biguanides (BG)
Experimental
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
Drug: LY2189265
Drug: Biguanides (BG)
LY2189265 + alpha-glucosidase inhibitor (a-GI)
Experimental
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
Drug: LY2189265
Drug: alpha-glucosidase inhibitor (a-GI)
LY2189265 + Thiazolidinedione (TZD)
Experimental
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
Drug: LY2189265
Drug: Thiazolidinedione (TZD)
LY2189265 + Glinides
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2189265
Drug
LY2189265 + Biguanides (BG)
LY2189265 + Glinides
LY2189265 + Sulfonylureas (SU)
LY2189265 + Thiazolidinedione (TZD)
LY2189265 + alpha-glucosidase inhibitor (a-GI)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Baseline through 52 Weeks
Percentage of Participants With Hypoglycemic Episodes
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Baseline through 52 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline, up to 26 Weeks and up to 52 Weeks
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
26 weeks and 52 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants who have had a diagnosis of type 2 diabetes mellitus before screening
Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2)
Exclusion Criteria:
Participants who have a diagnosis of type 1 diabetes
Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening
Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening
Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening
Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
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 9AM-5PM 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.
Aichi
466-0815
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LY2189265 + Sulfonylureas (SU)
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
FG001
LY2189265 + Biguanides (BG)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Non-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
Experimental
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Drug: LY2189265
Drug: Glinides
Dulaglutide
Sulfonylureas (SU)
Drug
SU is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + Sulfonylureas (SU)
Biguanides (BG)
Drug
Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + Biguanides (BG)
alpha-glucosidase inhibitor (a-GI)
Drug
a-GI is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + alpha-glucosidase inhibitor (a-GI)
Thiazolidinedione (TZD)
Drug
TZD is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + Thiazolidinedione (TZD)
Glinides
Drug
Glinides is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + Glinides
Change From Baseline in Fasting Blood Glucose (FBG)
Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.
Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in Body Weight
Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).
Baseline, up to 26 weeks and up to 52 weeks
Japan
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.
Chiba
277-0825
Japan
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.
Hokkaido
050-0073
Japan
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.
Hyōgo
662-0971
Japan
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.
Ibaraki
300-0053
Japan
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.
Kanagawa
231-0023
Japan
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.
Kyoto
615-8125
Japan
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.
Nagano
390-1401
Japan
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.
Okayama
700-8558
Japan
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.
Osaka
560-0082
Japan
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.
Saitama
3438577
Japan
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.
Tokyo
1030002
Japan
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.
Toyama
930-0859
Japan
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.
Wakayama
644-0011
Japan
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
FG002
LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
FG003
LY2189265 + Thiazolidin Edione (TZD)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
FG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
FG000131 subjects
FG00161 subjects
FG00265 subjects
FG00366 subjects
FG00471 subjects
Received at Least 1 Dose of Study Drug
FG000131 subjects
FG00161 subjects
FG00265 subjects
FG00366 subjects
FG00471 subjects
COMPLETED
FG000121 subjects
FG00159 subjects
FG00257 subjects
FG00363 subjects
FG00466 subjects
NOT COMPLETED
FG00010 subjects
FG0012 subjects
FG0028 subjects
FG0033 subjects
FG0045 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG0011 subjects
FG0026 subjects
FG0032 subjects
FG0042 subjects
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
All enrolled participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
BG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
BG002
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
BG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
BG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000131
BG00161
BG00265
BG00366
BG00471
BG005394
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.68± 11.59
BG00152.69± 10.19
BG00259.13± 10.51
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00036
BG00121
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Japan
Title
Measurements
BG000131
BG00161
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
All enrolled participants who received at least 1 dose of study drug
Posted
Number
percentage of participants
Baseline through 52 Weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000131
OG00161
OG00265
OG003
Title
Denominators
Categories
Title
Measurements
OG00085.5
OG00183.6
OG00270.8
OG003
Primary
Percentage of Participants With Hypoglycemic Episodes
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
All enrolled participants who received at least 1 dose of study drug
Posted
Number
percentage of participants
Baseline through 52 Weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
LY2189265 + a-GI
Secondary
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. Last observation carried forward (LOCF) was used to impute missing postbaseline values.
Posted
Mean
Standard Error
percentage of HbA1c
Baseline, up to 26 Weeks and up to 52 Weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
Secondary
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. LOCF was used to impute missing postbaseline values.
Posted
Number
percentage of participants
26 weeks and 52 weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
Secondary
Change From Baseline in Fasting Blood Glucose (FBG)
Participants who were randomized and received at least 1 dose of study drug with evaluable FBG data. LOCF was used to impute missing postbaseline values.
Posted
Mean
Standard Error
milligrams/deciliters (mg/dL)
Baseline, up to 26 weeks and up to 52 weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
Secondary
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.
Participants who were randomized and received at least 1 dose of study drug with evaluable SMBG data. LOCF was used to impute missing postbaseline. values.
Posted
Mean
Standard Error
mg/dL
Baseline, up to 26 weeks and up to 52 weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
Secondary
Change From Baseline in Body Weight
Participants who were randomized and received at least 1 dose of study drug with evaluable body weight data. LOCF was used to impute missing postbaseline values.
Posted
Mean
Standard Error
kilograms (kg)
Baseline, up to 26 weeks and up to 52 weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
Secondary
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).
Participants who were randomized and received at least 1 dose of study drug with evaluable HOMA2 data. LOCF was used to impute missing postbaseline values.
Posted
Mean
Standard Error
percentage of HOMA2
Baseline, up to 26 weeks and up to 52 weeks
ID
Title
Description
OG000
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
OG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
OG002
LY2189265 + a-GI
Time Frame
Not provided
Description
Not provided
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
LY2189265 + SU
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
9
131
112
131
EG001
LY2189265 + BG
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
3
61
51
61
EG002
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
4
65
46
65
EG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
1
66
53
66
EG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
3
71
52
71
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG0030 events0 affected66 at risk
EG0040 events0 affected71 at risk
Angina unstable
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Pancreatic enzyme abnormality
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Oedema
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Benign soft tissue neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Ovarian neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected10 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected95 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected55 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events1 affected61 at risk
EG0021 events1 affected65 at risk
EG0030 events0 affected66 at risk
EG0040 events0 affected71 at risk
Polycythaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Asthenopia
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Blepharitis
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Dry eye
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Glaucoma
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Iritis
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Macular oedema
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Photophobia
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0004 events2 affected131 at risk
EG0011 events1 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0008 events4 affected131 at risk
EG0010 events0 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0005 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Acute abdomen
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00022 events20 affected131 at risk
EG0013 events3 affected61 at risk
EG0028 events8 affected65 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00014 events13 affected131 at risk
EG00113 events9 affected61 at risk
EG0023 events3 affected65 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00018 events6 affected131 at risk
EG0012 events2 affected61 at risk
EG0022 events1 affected65 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0013 events3 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Gastritis atrophic
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gastrointestinal hypomotility
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0011 events1 affected61 at risk
EG0024 events3 affected65 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00082 events17 affected131 at risk
EG0012 events2 affected61 at risk
EG0028 events4 affected65 at risk
EG003
Pancreatic enzyme abnormality
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG00011 events8 affected131 at risk
EG0011 events1 affected61 at risk
EG0023 events3 affected65 at risk
EG003
Chest discomfort
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Chest pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Facial pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Fatigue
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Feeling abnormal
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site bruising
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site discomfort
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site eczema
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site erythema
General disorders
MedDRA 16.1
Systematic Assessment
EG0003 events2 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site induration
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site pruritus
General disorders
MedDRA 16.1
Systematic Assessment
EG0004 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Injection site reaction
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Injection site swelling
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Local swelling
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Malaise
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Oedema
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Oedema peripheral
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Xerosis
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0011 events1 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Hepatitis alcoholic
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Adenoiditis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00014 events10 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cystitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Eczema infected
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Furuncle
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0013 events3 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0006 events6 affected131 at risk
EG0017 events7 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG00051 events31 affected131 at risk
EG00125 events16 affected61 at risk
EG00215 events11 affected65 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Paronychia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0008 events7 affected131 at risk
EG0012 events2 affected61 at risk
EG0023 events3 affected65 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Skin infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0012 events2 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Viral infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0014 events4 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Heat stroke
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Tooth injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Amylase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0004 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Blood pressure decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Blood pressure increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Blood urea increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Lipase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG00011 events11 affected131 at risk
EG0016 events6 affected61 at risk
EG0027 events6 affected65 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0013 events3 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Weight decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Weight increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG00016 events10 affected131 at risk
EG0013 events3 affected61 at risk
EG0023 events3 affected65 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0008 events8 affected131 at risk
EG0012 events2 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Knee deformity
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0012 events2 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0004 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Nodal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0003 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Soft tissue neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Carotid arteriosclerosis
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0005 events4 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Migraine
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG00017 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Tremor
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0023 events1 affected65 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Decreased interest
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0002 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Diabetic nephropathy
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected10 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected55 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected95 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected55 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Varicocele
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cold urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0004 events3 affected131 at risk
EG0011 events1 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Leukoplakia
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Perivascular dermatitis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0006 events3 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected61 at risk
EG0022 events2 affected65 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Bladder catheterisation
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Cataract operation
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Colon polypectomy
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Coronary angioplasty
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Coronary artery bypass
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Dental care
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Duodenal sphincterotomy
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Open reduction of fracture
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Percutaneous coronary intervention
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Photocoagulation
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0003 events1 affected131 at risk
EG0012 events1 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Skin lesion excision
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Flushing
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected65 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0005 events5 affected131 at risk
EG0013 events3 affected61 at risk
EG0024 events4 affected65 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected65 at risk
EG003
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
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
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
C555680
dulaglutide
D013453
Sulfonylurea Compounds
D001645
Biguanides
D065089
Glycoside Hydrolase Inhibitors
C089946
2,4-thiazolidinedione
Ancestor Terms
ID
Term
D014508
Urea
D000577
Amides
D009930
Organic Chemicals
D013450
Sulfones
D013457
Sulfur Compounds
D006146
Guanidines
D000578
Amidines
D004791
Enzyme Inhibitors
D045504
Molecular Mechanisms of Pharmacological Action
D020228
Pharmacologic Actions
D020164
Chemical Actions and Uses
D007004
Hypoglycemic Agents
D045505
Physiological Effects of Drugs
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
1 subjects
1 subjects
0 subjects
56.40
± 10.51
BG00458.17± 10.30
BG00557.35± 10.96
10
BG00314
BG00417
BG00598
Male
BG00095
BG00140
BG00255
BG00352
BG00454
BG005296
0
BG0030
BG0040
BG0050
Asian
BG000131
BG00161
BG00265
BG00366
BG00471
BG005394
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
65
BG00366
BG00471
BG005394
66
OG00471
80.3
OG00473.2
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000131
OG00161
OG00265
OG00366
OG00471
Title
Denominators
Categories
Title
Measurements
OG00033.6
OG0013.3
OG0026.2
OG0036.1
OG0049.9
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000131
OG00161
OG00265
OG00366
OG00471
Title
Denominators
Categories
26 Weeks
Title
Measurements
OG000-1.93± 0.09
OG001-1.58± 0.11
OG002-1.67± 0.10
OG003-1.71± 0.13
OG004-1.80± 0.12
52 Weeks
Title
Measurements
OG000-1.67± 0.09
OG001-1.57± 0.11
OG002-1.65± 0.11
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
OG002
OG003
OG004
HbA1c at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-1.77
2-Sided
95
-1.87
-1.67
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
HbA1c at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-1.65
2-Sided
95
-1.75
-1.55
No
Superiority or Other
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000131
OG00161
OG00265
OG00366
OG00471
Title
Denominators
Categories
HbA1c ≤6.5% at Week 26
Title
Measurements
OG00035.1
OG00154.1
OG00272.3
OG00360.6
OG00453.5
HbA1c ≤6.5% at Week 52
Title
Measurements
OG00031.3
OG00157.4
OG00270.8
OG003
HbA1c <7.0% at Week 26
Title
Measurements
OG00061.8
OG00173.8
OG00281.5
OG003
HbA1c <7.0% at Week 52
Title
Measurements
OG00048.9
OG00173.8
OG00283.1
OG003
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000131
OG00161
OG00265
OG00366
OG00471
Title
Denominators
Categories
26 Weeks
Title
Measurements
OG000-46.8± 4.2
OG001-37.9± 4.0
OG002-46.8± 4.7
OG003-42.1± 4.5
OG004-42.7± 3.9
52 Weeks
Title
Measurements
OG000-43.2± 3.8
OG001-36.0± 4.2
OG002-47.0± 4.7
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
OG002
OG003
OG004
FBG at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Median Difference (Final Values)
-43.9
2-Sided
95
-47.8
-40.0
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
FBG at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-42.6
2-Sided
95
-46.4
-38.7
No
Superiority or Other
LY2189265 + a-GI
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000131
OG00161
OG00265
OG00366
OG00471
Title
Denominators
Categories
Pre-morning mean at 26 Weeks (n=131,61,64,66,71)
Title
Measurements
OG000-44.70± 4.57
OG001-34.60± 3.88
OG002-45.97± 4.99
OG003-35.40± 3.85
OG004-48.26± 4.33
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)
Title
Measurements
OG000-42.93± 3.89
OG001-37.19± 3.83
OG002-45.69± 5.05
OG003
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)
Title
Measurements
OG000-69.66± 5.69
OG001-64.23± 6.35
OG002-73.43± 6.70
OG003
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)
Title
Measurements
OG000-58.50± 5.63
OG001-63.81± 7.22
OG002-73.62± 7.27
OG003
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)
Title
Measurements
OG000-49.95± 4.85
OG001-26.26± 4.93
OG002-54.75± 6.24
OG003
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)
Title
Measurements
OG000-43.90± 5.15
OG001-33.34± 5.12
OG002-55.96± 6.42
OG003
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)
Title
Measurements
OG000-67.24± 5.24
OG001-50.03± 5.70
OG002-67.70± 7.37
OG003
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)
Title
Measurements
OG000-57.27± 5.44
OG001-52.70± 5.26
OG002-63.47± 7.12
OG003
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)
Title
Measurements
OG000-44.57± 5.63
OG001-25.66± 5.28
OG002-57.82± 6.83
OG003
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)
Title
Measurements
OG000-43.90± 5.39
OG001-25.34± 5.55
OG002-54.66± 7.35
OG003
2hr postevening meal at 26Weeks(n=128,61,65,66,69)
Title
Measurements
OG000-62.24± 6.05
OG001-45.41± 6.71
OG002-71.15± 7.57
OG003
2hr postevening meal at 52Weeks(n=128,61,65,66,69)
Title
Measurements
OG000-58.98± 5.71
OG001-48.61± 6.45
OG002-63.82± 7.00
OG003
Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)
Title
Measurements
OG000-61.07± 5.08
OG001-49.98± 6.48
OG002-63.98± 6.90
OG003
Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)
Title
Measurements
OG000-54.07± 5.24
OG001-52.70± 6.45
OG002-66.74± 7.31
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
OG002
OG003
OG004
Pre-morning meal at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-42.42
2-Sided
95
-46.55
-38.29
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Pre-morning meal at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-42.60
2-Sided
95
-46.44
-38.76
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
2 hours post-morning meal at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-68.48
2-Sided
95
-74.18
-62.79
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
2 hours post-morning meal at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-66.08
2-Sided
95
-72.12
-60.04
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Pre-midday meal at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-48.21
2-Sided
95
-53.32
-43.09
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Pre-midday meal at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-47.51
2-Sided
95
-52.77
-42.24
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
2 hours post-midday meal at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-67.06
2-Sided
95
-73.02
-61.11
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
2 hours post-midday meal at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-63.17
2-Sided
95
-69.16
-57.18
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Pre-evening meal at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-44.00
2-Sided
95
-49.67
-38.34
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Pre-evening meal at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-43.88
2-Sided
95
-49.55
-38.21
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
2 hours post-evening meal at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-62.91
2-Sided
95
-69.32
-56.50
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
2 hours post-evening meal at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-60.84
2-Sided
95
-66.95
-54.74
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Bedtime meal at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-61.15
2-Sided
95
-66.93
-55.37
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Bedtime meal at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
-60.16
2-Sided
95
-66.07
-54.25
No
Superiority or Other
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000131
OG00161
OG00265
OG00366
OG00471
Title
Denominators
Categories
26 Weeks
Title
Measurements
OG0000.02± 0.22
OG001-0.74± 0.39
OG002-1.22± 0.33
OG0030.78± 0.30
OG0040.19± 0.25
52 Weeks
Title
Measurements
OG0000.10± 0.24
OG001-0.87± 0.40
OG002-1.24± 0.42
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
OG002
OG003
OG004
Body weight at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.277
Mean Difference (Final Values)
-0.14
2-Sided
95
-0.40
0.12
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Body weight at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
0.382
Mean Difference (Final Values)
-0.13
2-Sided
95
-0.42
0.16
No
Superiority or Other
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
OG003
LY2189265 + TZD
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
OG004
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
Units
Counts
Participants
OG000127
OG00159
OG00262
OG00359
OG00464
Title
Denominators
Categories
HOMA2-%B, 26 Weeks
Title
Measurements
OG00029.10± 2.75
OG00128.15± 2.79
OG00230.88± 3.25
OG00327.34± 2.60
OG00426.93± 2.59
HOMA2-%B, 52 Weeks
Title
Measurements
OG00026.06± 2.77
OG00126.05± 2.97
OG00228.06± 3.61
OG003
HOMA2-%S, 26 Weeks
Title
Measurements
OG000-4.80± 3.40
OG001-3.48± 4.39
OG0027.57± 5.60
OG003
HOMA2-%S, 52 Weeks
Title
Measurements
OG000-3.99± 3.18
OG001-3.83± 4.89
OG0026.86± 5.24
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
OG002
OG003
OG004
HOMA2-B% at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
28.59
2-Sided
95
26.00
31.18
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
HOMA2-B% at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
<0.001
Mean Difference (Final Values)
27.57
2-Sided
95
24.73
30.41
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
HOMA2-S% at 26 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05
0.194
Mean Difference (Final Values)
-2.57
2-Sided
95
-6.46
1.32
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
HOMA2-S% at 52 Weeks
t-test, 2 sided
p-values are from within-group change t-test at the level of 0.05