Effects of LY2189265 on Glycemic Control in Participants... | NCT00791479 | Trialant
NCT00791479
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Dec 10, 2014Estimated
Enrollment
167Actual
Phase
Phase 2
Conditions
Diabetes Mellitus, Type 2
Interventions
LY2189265 and Lifestyle Measures
Placebo solution and Lifestyle Measures
Countries
United States
Croatia
Denmark
India
Mexico
Poland
Puerto Rico
Russia
Spain
Protocol Section
Identification Module
NCT ID
NCT00791479
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12565
Secondary IDs
ID
Type
Description
Link
H9X-MC-GBCK
Other Identifier
Eli Lilly and Company
CTRI/2009/091/000105
Registry Identifier
India
Brief Title
Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
Official Title
Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Dec 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2008
Primary Completion Date
Jan 2010Actual
Completion Date
Jan 2010Actual
First Submitted Date
Nov 12, 2008
First Submission Date that Met QC Criteria
Nov 12, 2008
First Posted Date
Nov 14, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 3, 2014
Results First Submitted that Met QC Criteria
Dec 8, 2014
Results First Posted Date
Dec 10, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 25, 2010
Certification/Extension First Submitted that Passed QC Review
Oct 25, 2010
Certification/Extension First Posted Date
Oct 27, 2010Estimated
Last Update Submitted Date
Dec 8, 2014
Last Update Posted Date
Dec 10, 2014Estimated
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 is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.
Detailed Description
Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram [mg]) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which participants will be randomized into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after randomization for those participants whose hyperglycemia reached pre-defined unacceptable high values. Participants on rescue therapy remained in the study and continued to receive study drug. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3 discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of participants and the short treatment duration.
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Diabetes, type 2 diabetes
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
167Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
0.1 milligram (mg) LY2189265
Experimental
LY2189265: 0.1 milligram (mg), subcutaneous (SC), once weekly (QW)
Drug: LY2189265 and Lifestyle Measures
0.5 milligram (mg) LY2189265
Experimental
LY2189265: 0.5 milligram (mg), subcutaneous (SC), once weekly (QW)
Drug: LY2189265 and Lifestyle Measures
1.0 milligram (mg) LY2189265
Experimental
LY2189265: 1.0 milligram (mg), subcutaneous (SC), once weekly (QW)
Drug: LY2189265 and Lifestyle Measures
1.5 milligram (mg) LY2189265
Experimental
LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)
Drug: LY2189265 and Lifestyle Measures
Placebo
Placebo Comparator
Placebo: subcutaneous (SC) once weekly (QW)
Drug: Placebo solution and Lifestyle Measures
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2189265 and Lifestyle Measures
Drug
Subcutaneous injection once-weekly for up to 12 weeks
0.1 milligram (mg) LY2189265
0.5 milligram (mg) LY2189265
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
Baseline, 12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.
Baseline, 4 weeks, 8 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diabetes mellitus, type 2
Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy >6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m^2, inclusive.
Stable weight for 3 months prior to screening
Exclusion Criteria:
Diabetes mellitus, type 1
Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
Use of medications (prescription or over-the counter) to promote weight loss
Chronic (>2 weeks) use of systemic glucocorticoid therapy
Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release [SR])
Cardiovascular event within 6 months prior to screening
Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times upper limit of normal
Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance <60 milliliter (mL)/minute which are determined by central labs at the time of screening
Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
Significant active, uncontrolled endocrine or autoimmune abnormality
History of a transplanted organ (corneal transplants are allowed)
Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
Sponsor employees
Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
Have previously completed or withdrawn from this study after providing informed consent
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Chair
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.
Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabet Med. 2012 Oct;29(10):1260-7. doi: 10.1111/j.1464-5491.2012.03745.x.
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
FG001
0.5 Milligrams (mg) LY2189265
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
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
1.0 milligram (mg) LY2189265
1.5 milligram (mg) LY2189265
Dulaglutide
Placebo solution and Lifestyle Measures
Drug
Subcutaneous injection once-weekly for up to 12 weeks
Placebo
Change From Baseline in Fasting Blood Glucose
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.
Baseline, 12 weeks
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.
12 weeks
Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.
Baseline, 12 weeks
Change From Baseline in Beta-cell Function (HOMA2-%B)
Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.
Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.
Baseline, 12 weeks
Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Baseline, 12 weeks
Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Baseline, 12 weeks
Change From Baseline in Pulse Rate
Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Baseline, 12 weeks
Change From Baseline in Blood Pressure (BP)
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Baseline, 12 weeks
Number of Participants With Self-reported Hypoglycemic Events
Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 12 weeks
Rate of Self-reported Hypoglycemic Events
Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.
Baseline through 12 weeks
Treatment Emergent Adverse Events
A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 12 weeks
Change From Baseline in Body Weight
Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Baseline, 12 weeks
Antibody Production and Effects to LY2189265
LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
Baseline, 4 weeks, 12 weeks, 16 weeks
Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
4 weeks, 8 weeks, 12 weeks
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lancaster
California
93534
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mission Hills
California
91345
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Palm Springs
California
92262
United States
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.
Vincennes
Indiana
47591
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wichita
Kansas
67208
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bloomfield Hills
Michigan
48302
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Calabash
North Carolina
28467
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tabor City
North Carolina
28463
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beaver
Pennsylvania
15009
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
North Myrtle Beach
South Carolina
29582
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Menomonee Falls
Wisconsin
53051
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dubrovnik
20000
Croatia
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.
Osijek
HR-31000
Croatia
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.
Varaždin
HR-42000
Croatia
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.
Zagreb
HR-10000
Croatia
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.
Aalborg
DK-9000
Denmark
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.
Aarhus
8000
Denmark
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.
Copenhagen
2300
Denmark
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.
Copenhagen
2400
Denmark
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.
Frederiksberg
2000
Denmark
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.
Hillerød
Dk-3400
Denmark
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.
Bangalore
560052
India
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.
Bilāspur
495006
India
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.
Hyderabaad
500001
India
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.
Indore
452001
India
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.
Kochi
682026
India
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.
Mumbai
400 067
India
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.
New Delhi
110 029
India
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.
Mexico City
06700
Mexico
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.
Monterrey
64570
Mexico
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.
Bialystok
15-950
Poland
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.
Szczecin
71-252
Poland
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.
Wroclaw
503-349
Poland
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.
Carolina
00983
Puerto Rico
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.
San German
00685
Puerto Rico
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.
Arkhangelsk
163045
Russia
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.
Moscow
119881
Russia
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.
Rostov-on-Don
344022
Russia
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.
Saint Petersburg
193257
Russia
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.
Alzira
46600
Spain
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.
Dos Hermanas
41014
Spain
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.
Lleida
25198
Spain
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.
Málaga
29010
Spain
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.
Santa Cruz de Tenerife
38320
Spain
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.
Torrevieja
03186
Spain
LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
FG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
FG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
FG004
3.0 Milligrams (mg) LY2189265
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
FG005
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
FG00035 subjects
FG00134 subjects
FG00234 subjects
FG00329 subjects
FG0043 subjects3mg LY2189265 discont. Replaced with 1.5mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474
FG00532 subjects
Received at Least One Dose of Study Drug
FG00035 subjects
FG00134 subjects
FG00234 subjects
FG00329 subjects
FG0043 subjects
FG00532 subjects
COMPLETED
FG00033 subjects
FG00131 subjects
FG00234 subjects
FG00325 subjects
FG0040 subjects
FG00529 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0020 subjects
FG0034 subjects
FG0043 subjects
FG0053 subjects
Type
Comment
Reasons
Dose Discontinued per Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
BG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
BG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
BG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
BG004
3.0 Milligrams (mg) LY2189265
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
BG005
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00134
BG00234
BG00329
BG0043
BG00532
BG006167
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
BG00056.33± 9.15
BG00156.91± 9.06
BG00257.16± 8.76
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00118
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0001
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00016
BG00115
BG002
Body Mass Index (BMI)
Body mass index is an estimate of body fat based on body weight divided by height squared.
Mean
Standard Deviation
kilograms/square meters (kg/m^2)
Title
Denominators
Categories
Title
Measurements
BG00032.92± 4.75
BG00132.26± 5.39
Duration of Diabetes
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0003.90± 3.19
BG0013.72± 3.80
BG002
Body Weight
Mean
Standard Deviation
kilogram (kg)
Title
Denominators
Categories
Title
Measurements
BG00087.08± 17.28
BG00190.20± 21.34
BG002
Glycosylated Hemoglobin (HbA1c)
Mean
Standard Deviation
percentage of glycosylated hemoglobin
Title
Denominators
Categories
Title
Measurements
BG0007.13± 0.55
BG0017.18± 0.60
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
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
percentage of glycosylated hemoglobin
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
Units
Counts
Participants
OG00034
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.37± 0.11
OG001-0.89± 0.12
OG002-1.03± 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
Test of log linear dose response with placebo.
Mixed Models Analysis
<0.001
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Secondary
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.
Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
percentage of glycosylated hemoglobin
Baseline, 4 weeks, 8 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Secondary
Change From Baseline in Fasting Blood Glucose
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.
Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
milligrams per deciliter (mg/dL)
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Secondary
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.
Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.
Posted
Number
percentage of participants
12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
Secondary
Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.
Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
milligrams per deciliter (mg/dL)
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Secondary
Change From Baseline in Beta-cell Function (HOMA2-%B)
Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.
Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
percentage of HOMA2-%B
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
Secondary
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.
Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
percentage of HOMA2-%S
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
Secondary
Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.
Posted
Least Squares Mean
Standard Error
millisecond (msec)
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
Secondary
Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Participants who received at least one dose of study drug and have heart rate change from baseline data available.
Posted
Least Squares Mean
Standard Error
beats per minute (bpm)
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
Secondary
Change From Baseline in Pulse Rate
Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Participants who received at least one dose of study drug and have pulse rate change from baseline data available.
Posted
Least Squares Mean
Standard Error
beats per minute (bpm)
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
Secondary
Change From Baseline in Blood Pressure (BP)
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Participants who received at least one dose of study drug and have blood pressure change from baseline data available.
Posted
Least Squares Mean
Standard Error
millimeters of mercury (mmHg)
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Secondary
Number of Participants With Self-reported Hypoglycemic Events
Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
Posted
Number
participants
Baseline through 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Secondary
Rate of Self-reported Hypoglycemic Events
Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.
Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
Events per participant per year
Baseline through 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
Secondary
Treatment Emergent Adverse Events
A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who received at least one dose of study drug.
Posted
Number
participants
Baseline through 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Secondary
Change From Baseline in Body Weight
Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
Participants who received at least one dose of study drug and have body weight change from baseline data available.
Posted
Least Squares Mean
Standard Error
kilogram (kg)
Baseline, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
Secondary
Antibody Production and Effects to LY2189265
LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.
Posted
Number
participants
Baseline, 4 weeks, 12 weeks, 16 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Secondary
Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams [mg]) with evaluable pharmacokinetic data.
Posted
Mean
Standard Deviation
nanograms*hour/milliliter (ng*h/mL)
4 weeks, 8 weeks, 12 weeks
ID
Title
Description
OG000
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
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
0.1 Milligrams (mg) LY2189265
LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
0
35
20
35
EG001
0.5 Milligrams (mg) LY2189265
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1
34
16
34
EG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1
34
17
34
EG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1
29
15
29
EG004
3.0 Milligrams (mg) LY2189265
LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
0
3
1
3
EG005
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1
32
15
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial flutter
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG0030 events0 affected29 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected32 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pancreatitis haemorrhagic
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected29 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected32 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0007 events2 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events2 affected35 at risk
EG0014 events3 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0004 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0004 events4 affected35 at risk
EG0010 events0 affected34 at risk
EG0024 events4 affected34 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Fatigue
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hunger
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site haematoma
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Otitis media
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Neck injury
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Laboratory test abnormal
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lipase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events2 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0002 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0025 events4 affected34 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 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
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
0 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0 subjects
FG0051 subjects
57.45
± 7.88
BG00460.82± 7.15
BG00555.03± 9.33
BG00656.64± 8.78
18
BG00316
BG0042
BG00514
BG00692
Male
BG00011
BG00116
BG00216
BG00313
BG0041
BG00518
BG00675
2
BG0030
BG0040
BG0050
BG0063
Asian
Title
Measurements
BG0004
BG0015
BG0025
BG0034
BG0040
BG0055
BG00623
Black or African American
Title
Measurements
BG0001
BG0011
BG0020
BG0031
BG0041
BG0051
BG0065
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
White
Title
Measurements
BG00029
BG00128
BG00226
BG00324
BG0042
BG00525
BG006134
Multiple
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
13
BG00311
BG0043
BG00517
BG00675
Mexico
Title
Measurements
BG0005
BG0015
BG0024
BG0034
BG0040
BG0055
BG00623
Puerto Rico
Title
Measurements
BG0000
BG0011
BG0022
BG0032
BG0040
BG0050
BG0065
Spain
Title
Measurements
BG0002
BG0013
BG0021
BG0031
BG0040
BG0051
BG0068
Poland
Title
Measurements
BG0002
BG0012
BG0025
BG0035
BG0040
BG0052
BG00616
Croatia
Title
Measurements
BG0004
BG0012
BG0022
BG0033
BG0040
BG0053
BG00614
Russian Federation
Title
Measurements
BG0002
BG0011
BG0022
BG0030
BG0040
BG0050
BG0065
India
Title
Measurements
BG0004
BG0015
BG0025
BG0033
BG0040
BG0054
BG00621
BG00232.22± 4.50
BG00331.04± 4.29
BG00435.38± 3.96
BG00532.07± 5.23
BG00632.20± 4.83
3.28
± 2.54
BG0034.62± 4.08
BG0045.00± 3.04
BG0053.91± 4.74
BG0063.88± 3.68
86.89
± 16.95
BG00385.81± 18.63
BG004100.90± 25.51
BG00590.87± 18.94
BG00688.43± 18.68
7.28
± 0.66
BG0037.25± 0.43
BG0047.63± 0.15
BG0057.36± 0.63
BG0067.24± 0.58
21
OG00428
-1.04
± 0.13
OG0040.01± 0.13
Test of log linear dose response without placebo.
Mixed Models Analysis
<0.001
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.069
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-0.37
No
Superiority or Other
OG001
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-0.89
No
Superiority or Other
OG002
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-1.04
No
Superiority or Other
OG003
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-1.04
No
Superiority or Other
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00035
OG00134
OG00234
OG00326
OG00429
Title
Denominators
Categories
Week 4 (n=35, n=34, n=34, n=25, n=29)
Title
Measurements
OG000-0.28± 0.09
OG001-0.51± 0.09
OG002-0.46± 0.08
OG003-0.53± 0.10
OG004-0.01± 0.10
Week 8 (n=35, n=30, n=33, n=24, n=28)
Title
Measurements
OG000-0.33± 0.10
OG001-0.74± 0.10
OG002-0.78± 0.10
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
Test of log linear dose response with placebo.
Mixed Models Analysis
<0.001
Treatment comparison at Week 4. A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Test of log linear dose response without placebo.
Mixed Models Analysis
0.023
Treatment comparison at Week 4. A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Test of log linear dose response with placebo.
Mixed Models Analysis
<0.001
Treatment comparison at Week 8. A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Test of log linear dose response without placebo.
Mixed Models Analysis
<0.001
Treatment comparison at Week 8. A priori threshold for statistical significance was P<0.05.
No
Superiority or Other
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00035
OG00134
OG00234
OG00328
OG00431
Title
Denominators
Categories
Title
Measurements
OG000-11.59± 4.09
OG001-30.31± 4.26
OG002-33.73± 4.18
OG003-37.49± 4.78
OG004-3.78± 4.44
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
Test of log linear dose response with placebo.
Mixed Models Analysis
<0.001
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Test of log linear dose response without placebo.
Mixed Models Analysis
<0.001
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.456
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-7.81
No
Superiority or Other
OG001
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-26.53
No
Superiority or Other
OG002
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-29.96
No
Superiority or Other
OG003
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-33.71
No
Superiority or Other
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00035
OG00134
OG00234
OG00329
OG00432
Title
Denominators
Categories
HbA1c levels <7.0% (n=34, n=30, n=32, n=21, n=28)
Title
Measurements
OG00047.1
OG00173.3
OG00275.0
OG00371.4
OG00421.4
HbA1c levels ≤6.5% (n=34, n=30, n=32, n=21, n=28)
Title
Measurements
OG00014.7
OG00153.3
OG00250.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Cochran-Armitage trend test
The Cochran-Armitage trend test included the placebo arm.
<0.001
Treatment comparison of glycosylated hemoglobin (HbA1c) levels <7.0%.
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Cochran-Armitage trend test
The Cochran-Armitage trend test included the placebo arm.
<0.001
Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.
No
Superiority or Other
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00034
OG00132
OG00233
OG00328
OG00431
Title
Denominators
Categories
Title
Measurements
OG000-15.77± 4.74
OG001-32.21± 4.88
OG002-42.46± 4.68
OG003-44.79± 5.46
OG004-6.12± 5.05
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
Test of log linear dose response with placebo.
Mixed Models Analysis
<0.001
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Test of log linear dose response without placebo.
Mixed Models Analysis
<0.001
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.378
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-9.65
No
Superiority or Other
OG001
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-26.09
No
Superiority or Other
OG002
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-36.34
No
Superiority or Other
OG003
OG004
Mixed Models Analysis
<0.001
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-38.67
No
Superiority or Other
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00034
OG00134
OG00228
OG00326
OG00431
Title
Denominators
Categories
Title
Measurements
OG00013.18± 6.76
OG00131.66± 7.04
OG00239.04± 7.64
OG00329.29± 8.11
OG004-2.06± 7.44
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
Test of log linear dose response with placebo.
Mixed Models Analysis
<0.001
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Test of log linear dose response without placebo.
Mixed Models Analysis
0.036
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00027
OG00133
OG00229
OG00324
OG00422
Title
Denominators
Categories
Title
Measurements
OG000-2.41± 6.62
OG0016.10± 6.92
OG002-4.80± 7.44
OG00312.98± 7.95
OG0040.58± 7.34
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
Test of log linear dose response with placebo.
Mixed Models Analysis
0.450
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Test of log linear dose response without placebo.
Mixed Models Analysis
0.329
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00032
OG00131
OG00234
OG00325
OG00429
Title
Denominators
Categories
Fridericia-corrected QT (QTcF) Interval
Title
Measurements
OG0001.34± 2.09
OG001-1.18± 2.11
OG0024.56± 2.01
OG003-0.63± 2.33
OG0040.70± 2.19
PR Interval
Title
Measurements
OG0003.22± 2.20
OG0014.57± 2.23
OG002-0.55± 2.15
OG003
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00032
OG00131
OG00234
OG00325
OG00429
Title
Denominators
Categories
Title
Measurements
OG0001.38± 1.48
OG0011.16± 1.51
OG0021.88± 1.44
OG0034.18± 1.67
OG0040.67± 1.58
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00034
OG00131
OG00234
OG00325
OG00430
Title
Denominators
Categories
Title
Measurements
OG0000.19± 1.44
OG0010.25± 1.49
OG0021.02± 1.43
OG0031.34± 1.65
OG0041.29± 1.54
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00034
OG00131
OG00234
OG00325
OG00430
Title
Denominators
Categories
Sitting Systolic Blood Pressure
Title
Measurements
OG000-2.21± 2.04
OG0010.51± 2.12
OG002-2.57± 2.02
OG0031.88± 2.33
OG004-0.68± 2.18
Sitting Diastolic Blood Pressure
Title
Measurements
OG000-0.24± 1.21
OG0010.59± 1.26
OG0020.42± 1.20
OG003
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00035
OG00134
OG00234
OG00329
OG00432
Title
Denominators
Categories
Documented Symptomatic
Title
Measurements
OG0000
OG0012
OG0022
OG0033
OG0040
Asymptomatic
Title
Measurements
OG0001
OG0010
OG0020
OG003
Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Nocturnal
Title
Measurements
OG0001
OG0012
OG0021
OG003
LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG002
1.0 Milligrams (mg) LY2189265
LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00035
OG00134
OG00234
OG00329
OG00432
Title
Denominators
Categories
Documented Symptomatic Hypoglycemic Rate
Title
Measurements
OG000-0.08± 0.72
OG0010.25± 0.73
OG0021.68± 0.73
OG0030.61± 0.79
OG004-0.09± 0.75
Asymptomatic Hypoglycemic Rate
Title
Measurements
OG0000.19± 0.10
OG001-0.01± 0.10
OG002-0.01± 0.10
OG003
Severe Hypoglycemic Rate
Title
Measurements
OG0000± 0
OG0010± 0
OG0020± 0
OG003
Nocturnal Hypoglycemic Rate
Title
Measurements
OG0000.20± 0.62
OG0010.16± 0.64
OG0021.21± 0.62
OG003
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
3.0 Milligrams (mg) LY2189265
LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG005
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00035
OG00134
OG00234
OG00329
OG0043
OG00532
Title
Denominators
Categories
Title
Measurements
OG00021
OG00117
OG00220
OG00318
OG0041
OG00518
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00034
OG00131
OG00234
OG00325
OG00430
Title
Denominators
Categories
Title
Measurements
OG000-0.19± 0.42
OG001-0.34± 0.43
OG002-1.11± 0.42
OG003-1.49± 0.48
OG004-1.38± 0.45
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
Test of log linear dose response with placebo.
Mixed Models Analysis
0.969
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG001
OG002
OG003
Test of log linear dose response without placebo.
Mixed Models Analysis
0.009
A priori threshold for statistical significance was p<0.05.
No
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.140
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
1.19
No
Superiority or Other
OG001
OG004
Mixed Models Analysis
0.247
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
1.04
No
Superiority or Other
OG002
OG004
Mixed Models Analysis
0.975
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
0.27
No
Superiority or Other
OG003
OG004
Mixed Models Analysis
1.00
An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
Mean Difference (Final Values)
-0.11
No
Superiority or Other
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
Units
Counts
Participants
OG00035
OG00134
OG00234
OG00329
OG00432
Title
Denominators
Categories
Week 4
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
Week 12
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 16
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
1.5 Milligrams (mg) LY2189265
LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
OG004
3.0 Milligrams (mg) LY2189265
LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks