A Study in Participants With Type 2 Diabetes Mellitus | NCT01064687 | Trialant
NCT01064687
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jan 26, 2015Estimated
Enrollment
978Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Interventions
LY2189265
Exenatide
Placebo
Metformin
Pioglitazone
Countries
United States
Argentina
Mexico
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT01064687
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11373
Secondary IDs
ID
Type
Description
Link
H9X-MC-GBDA
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Participants With Type 2 Diabetes Mellitus
Official Title
A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
Acronym
AWARD-1
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2010
Primary Completion Date
Nov 2011Actual
Completion Date
May 2012Actual
First Submitted Date
Feb 5, 2010
First Submission Date that Met QC Criteria
Feb 5, 2010
First Posted Date
Feb 8, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 3, 2014
Results First Submitted that Met QC Criteria
Jan 15, 2015
Results First Posted Date
Jan 26, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 10, 2012
Certification/Extension First Submitted that Passed QC Review
Feb 10, 2012
Certification/Extension First Posted Date
Feb 14, 2012Estimated
Last Update Submitted Date
Jan 15, 2015
Last Update Posted Date
Jan 26, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.
Detailed Description
During the study, if a participant developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, the participant received additional therapeutic intervention or initiation of an alternative antihyperglycemic medication following study drug discontinuation (rescue therapy). 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 analyses.
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
978Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1.5 mg LY2189265
Experimental
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Drug: LY2189265
Drug: Metformin
Drug: Pioglitazone
0.75 mg LY2189265
Experimental
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Drug: LY2189265
Drug: Metformin
Drug: Pioglitazone
Exenatide
Active Comparator
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Drug: Exenatide
Drug: Metformin
Drug: Pioglitazone
Placebo
Placebo Comparator
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52).
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2189265
Drug
0.75 mg LY2189265
1.5 mg LY2189265
Placebo
Dulaglutide
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Baseline, 26 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Baseline, 52 weeks
Change From Baseline to 26 Weeks for Body Weight
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications
Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
Willing to inject subcutaneous (SC) medication up to 2 times per day
Stable weight for 3 months prior to screening
Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m^2)
Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Exclusion Criteria:
Type 1 Diabetes
HbA1c equal to or less than 6.5 before randomization or at randomization
Chronic insulin use
Taking drugs to promote weight loss by prescription or over the counter
Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
History of fluid retention or edema
History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening
Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal
Acute or chronic pancreatitis of any form
Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min)
History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening
Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
Organ transplant except cornea
Have enrolled in another clinical trial within the last 30 days
Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study
Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Due to ethical considerations and to preserve the blinding of the study, participants randomized to placebo at baseline were reassigned at 26 weeks to either 1.5 mg LY2189265 or 0.75 mg LY2189265 from 26 weeks through 52 weeks.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks for Body Weight
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Change From Baseline to 26 Weeks on Body Mass Index (BMI)
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks on Body Mass Index (BMI)
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Baseline, 26 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Baseline, 52 weeks
Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-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). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-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). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Change From Baseline to 26 Weeks in the EuroQol 5
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
Baseline, 26 weeks
Change From Baseline to 52 Weeks in the EuroQol 5
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
Baseline, 52 weeks
Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version
The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). The DTSQ change version (DTSQc) was not collected at 26 weeks. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions
The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively. Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
Baseline, 52 weeks
Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks
Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event since the previous inquiry. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
Baseline through 52 weeks
Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval 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. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval 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. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Change in Baseline to 26 Weeks on Pulse Rate
Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change in Baseline to 52 Weeks on Pulse Rate
Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Change From Baseline to 26 Weeks on Blood Pressure
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 26 weeks
Change From Baseline to 52 Weeks on Blood Pressure
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Baseline, 52 weeks
Number of Participants With Adjudicated Pancreatitis at 26 Weeks
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 26 weeks
Number of Participants With Adjudicated Pancreatitis at 52 Weeks
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 52 weeks
Change From Baseline to 26 Weeks on Pancreatic Enzymes
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Baseline, 26 weeks
Change From Baseline to 52 Weeks on Pancreatic Enzymes
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Baseline, 52 weeks
Change From Baseline to 26 Weeks on Serum Calcitonin
Baseline, 26 weeks
Change From Baseline to 52 Weeks on Serum Calcitonin
Baseline, 52 weeks
Number of Self-reported Hypoglycemic Events at 26 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 26 weeks
Number of Self-reported Hypoglycemic Events at 52 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 52 weeks
Rate of Self-reported Hypoglycemic Events at 26 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 26 weeks
Rate of Self-reported Hypoglycemic Events at 52 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 52 weeks
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
Baseline through 26 weeks
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
Baseline through 52 weeks
Number of Participants With LY2189265 Antibodies at 26 Weeks
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. 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 were summarized.
Baseline through 26 weeks
Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. 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 were summarized.
26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose
Number of Participants With Treatment Emergent Adverse Events at 26 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 26 weeks
Number of Participants With Treatment Emergent Adverse Events at 52 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through 52 weeks
Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values
Baseline, 26 weeks
Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values
Baseline, 52 weeks
Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
Baseline, 26 weeks
Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265
Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
4 weeks, 13 weeks, 26 weeks, and 52 weeks
United States
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Phoenix
Arizona
85028
United States
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Cathedral City
California
92234
United States
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Concord
California
94520
United States
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Fresno
California
93720
United States
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Greenbrae
California
94904
United States
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Lancaster
California
93534
United States
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Mission Hills
California
91345
United States
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Monterey
California
93940
United States
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National City
California
91950
United States
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Oceanside
California
92056
United States
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Paramount
California
90723
United States
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Roseville
California
95661
United States
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San Ramon
California
94583
United States
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Tustin
California
92780
United States
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New Britain
Connecticut
06050
United States
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Fort Lauderdale
Florida
33316
United States
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Hollywood
Florida
33021
United States
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Orlando
Florida
32806
United States
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Pembroke Pines
Florida
33027
United States
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West Palm Beach
Florida
33401
United States
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Atlanta
Georgia
30308
United States
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Honolulu
Hawaii
96813
United States
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Boise
Idaho
83702
United States
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Idaho Falls
Idaho
83404
United States
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Meridian
Idaho
83646
United States
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Crystal Lake
Illinois
60012
United States
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Peoria
Illinois
61615
United States
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Vincennes
Indiana
47591
United States
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Topeka
Kansas
66606
United States
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Madisonville
Kentucky
42431
United States
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New Orleans
Louisiana
70112
United States
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Bangor
Maine
04401
United States
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Biddeford
Maine
04005
United States
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Elkridge
Maryland
21075
United States
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Bloomfield Hills
Michigan
48302
United States
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Flint
Michigan
48503
United States
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St Louis
Missouri
63141
United States
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Nashua
New Hampshire
03063
United States
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Toms River
New Jersey
08753
United States
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Albany
New York
12206
United States
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Flushing
New York
11365
United States
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Syracuse
New York
13210
United States
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Asheville
North Carolina
28803
United States
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Cary
North Carolina
27518
United States
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Durham
North Carolina
27713
United States
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Morehead City
North Carolina
28557
United States
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Cincinnati
Ohio
45242
United States
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Cleveland
Ohio
44122
United States
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Columbus
Ohio
43210
United States
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Dayton
Ohio
45439
United States
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Delaware
Ohio
43015
United States
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Perrysburg
Ohio
43551
United States
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Bend
Oregon
97701
United States
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Corvallis
Oregon
97330
United States
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Eugene
Oregon
97401
United States
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Beaver
Pennsylvania
15009
United States
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Danville
Pennsylvania
17822
United States
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Levittown
Pennsylvania
19056
United States
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Philadelphia
Pennsylvania
19107
United States
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Wilkes-Barre
Pennsylvania
18711
United States
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Charleston
South Carolina
29412
United States
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Greenville
South Carolina
29605
United States
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Greer
South Carolina
29651
United States
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Myrtle Beach
South Carolina
29572
United States
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Memphis
Tennessee
38119
United States
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Arlington
Texas
76014
United States
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Austin
Texas
78731
United States
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Corpus Christi
Texas
78404
United States
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Dallas
Texas
75231
United States
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El Paso
Texas
79925
United States
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San Antonio
Texas
78258
United States
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Schertz
Texas
78154
United States
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Ogden
Utah
84403
United States
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St. George
Utah
84790
United States
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West Jordan
Utah
84088
United States
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Spokane
Washington
99202
United States
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Tacoma
Washington
98405
United States
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Buenos Aires
CBA 1419
Argentina
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Guadalajara
44600
Mexico
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Mexico City
6700
Mexico
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Monterrey
64461
Mexico
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Caguas
00726
Puerto Rico
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Hato Rey
00917
Puerto Rico
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Manati
00674
Puerto Rico
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Ponce
00716
Puerto Rico
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San German
00683
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 Juan
00907
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.
Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
FG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
FG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
FG000279 subjects
FG001280 subjects
FG002278 subjectsOf 278 participants randomized to Exenatide, 2 chose not to take study drug.
FG003141 subjects
Received at Least 1 Dose of Study Drug
FG000279 subjects
FG001280 subjects
FG002276 subjects
FG003141 subjects
Completed 26 Weeks
FG000260 subjects
FG001263 subjects
FG002252 subjects
FG003124 subjects
COMPLETED
FG000245 subjects
FG001254 subjects
FG002237 subjects
FG003124 subjects
NOT COMPLETED
FG00034 subjects
FG00126 subjects
FG00241 subjects
FG00317 subjects
Type
Comment
Reasons
Adverse Event
FG0009 subjects
FG0014 subjects
FG00210 subjects
FG0033 subjects
Death
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Entry Criteria Not Met
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
Lost to Follow-up
FG0007 subjects
FG00110 subjects
FG00213 subjects
FG0035 subjects
Physician Decision
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
Withdrawal by Subject
FG0009 subjects
FG0017 subjects
FG00212 subjects
FG0035 subjects
Treatment Noncompliance
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
BG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
BG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
BG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000279
BG001280
BG002276
BG003141
BG004976
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
BG00056.25± 9.72
BG00155.79± 9.45
BG00255.45± 10.15
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000116
BG001112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00093
BG001102
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00040
BG00137
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG000226
BG001226
BG002
Body Weight
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
Title
Measurements
BG00096.22± 19.63
BG00195.53± 20.56
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 per meter squared (kg/m^2)
Title
Denominators
Categories
Title
Measurements
BG00033.09± 5.33
BG00133.00± 5.50
Glycosylated Hemoglobin (HbA1c)
Mean
Standard Deviation
percentage of glycosylated hemoglobin
Title
Denominators
Categories
Title
Measurements
BG0008.10± 1.34
BG0018.05± 1.24
BG002
Duration of Diabetes
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0008.76± 5.59
BG0018.78± 5.47
BG002
Fasting Serum Glucose
Mean
Standard Deviation
millimoles per liter (mmol/L)
Title
Denominators
Categories
Title
Measurements
BG0009.00± 3.09
BG0018.84± 2.76
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 to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
percentage of glycosylated hemoglobin
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000271
OG001269
OG002266
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.51± 0.06
OG001-1.30± 0.06
OG002-0.99± 0.06
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
OG003
Superiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-1.05
2-Sided
95
-1.22
-0.88
No
Superiority or Other
Secondary
Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
percentage of glycosylated hemoglobin
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks for Body Weight
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable body weight data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
kilograms (kg)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks for Body Weight
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable body weight data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
kilograms (kg)
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks on Body Mass Index (BMI)
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable BMI data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
kilograms per meter squared (kg/m^2)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks on Body Mass Index (BMI)
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable BMI data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
kilograms per meter squared (kg/m^2)
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable SMPG data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
milligrams per deciliter (mg/dL)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable SMPG data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
milligrams per deciliter (mg/dL)
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Number
percentage of participants
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Secondary
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Number
percentage of participants
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Secondary
Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-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). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
percentage of HOMA2
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-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). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.
Posted
Least Squares Mean
Standard Error
percentage of HOMA2
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Change From Baseline to 26 Weeks in the EuroQol 5
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks in the EuroQol 5
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable EQ-5D data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version
The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). The DTSQ change version (DTSQc) was not collected at 26 weeks. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions
The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively. Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable DTSQs or DTSQc data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
Secondary
Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable APPADL data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
Secondary
Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable IW-SP data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks
Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event since the previous inquiry. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. The number of participants with adjudicated CV events was not collected at 26 weeks.
Posted
Number
participants
Baseline through 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval 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. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable ECG QTcF Interval or PR interval data.
Posted
Least Squares Mean
Standard Error
milliseconds (msec)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval 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. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable ECG QTcF Interval or PR Interval data.
Posted
Least Squares Mean
Standard Error
milliseconds (msec)
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change in Baseline to 26 Weeks on Pulse Rate
Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable seated pulse rate data.
Posted
Least Squares Mean
Standard Error
beats per minute (bpm)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change in Baseline to 52 Weeks on Pulse Rate
Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable seated pulse rate data.
Posted
Least Squares Mean
Standard Error
beats per minute (bpm)
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks on Blood Pressure
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable blood pressure data.
Posted
Least Squares Mean
Standard Error
millimeters of mercury (mmHg)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks on Blood Pressure
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable blood pressure data.
Posted
Mean
Standard Error
millimeters of mercury (mmHg)
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Participants With Adjudicated Pancreatitis at 26 Weeks
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.
Posted
Number
participants
Baseline through 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Participants With Adjudicated Pancreatitis at 52 Weeks
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.
Posted
Number
participants
Baseline through 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Secondary
Change From Baseline to 26 Weeks on Pancreatic Enzymes
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Median
Inter-Quartile Range
units per liter
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks on Pancreatic Enzymes
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Median
Inter-Quartile Range
units per liter
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks on Serum Calcitonin
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Mean
Standard Deviation
picograms per milliliter (pg/mL)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 52 Weeks on Serum Calcitonin
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Mean
Standard Deviation
picograms per milliliter (pg/mL)
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Self-reported Hypoglycemic Events at 26 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.
Posted
Number
events
Baseline through 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Number of Self-reported Hypoglycemic Events at 52 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.
Posted
Number
events
Baseline through 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Rate of Self-reported Hypoglycemic Events at 26 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo. Only pre-rescue measurements were used.
Posted
Mean
Standard Deviation
events per participant per year
Baseline through 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
Secondary
Rate of Self-reported Hypoglycemic Events at 52 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. Only pre-rescue measurements were used.
Posted
Mean
Standard Deviation
events per participant per year
Baseline through 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
Secondary
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.
Posted
Number
participants
Baseline through 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.
Posted
Number
participants
Baseline through 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Participants With LY2189265 Antibodies at 26 Weeks
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. 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 were summarized.
Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.
Posted
Number
participants
Baseline through 26 weeks
ID
Title
Description
OG000
0.75 mg LY2189265 or 1.5 mg LY2189265
LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Placebo
Secondary
Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. 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 were summarized.
Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.
Posted
Number
participants
26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose
ID
Title
Description
OG000
0.75 mg LY2189265 or 1.5 mg LY2189265
LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Participants With Treatment Emergent Adverse Events at 26 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.
Posted
Number
participants
Baseline through 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Number of Participants With Treatment Emergent Adverse Events at 52 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.
Posted
Number
participants
Baseline through 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.
Posted
Least Squares Mean
Standard Error
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Secondary
Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values
Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.
Posted
Least Squares Mean
Standard Error
Baseline, 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable NT-proBNP data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Posted
Median
Inter-Quartile Range
picograms per milliliter (pg/mL)
Baseline, 26 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Secondary
Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265
Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Participants who were randomized at baseline to LY2189265 and received at least 1 dose of study drug with evaluable AUC data.
Posted
Mean
Standard Deviation
nanogram hours per milliliter (ng*hr/mL)
4 weeks, 13 weeks, 26 weeks, and 52 weeks
ID
Title
Description
OG000
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
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
0.75 mg LY2189265 (Baseline Through 26 Weeks)
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
15
280
194
280
EG001
1.5 mg LY2189265 (Baseline Through 26 Weeks)
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
12
279
215
279
EG002
Exenatide (Baseline Through 26 Weeks)
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
15
278
196
278
EG003
Placebo (Baseline Through 26 Weeks)
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52)
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
12
141
103
141
EG004
0.75 mg LY2189265 (Baseline Through 56 Weeks)
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
22
280
218
280
EG005
1.5 mg LY2189265 (Baseline Through 56 Weeks)
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
18
279
228
279
EG006
Exenatide (Baseline Through 56 Weeks)
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
27
278
223
278
EG007
Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks)
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
All events were treatment emergent during the LY2189265 treatment period.
6
62
47
62
EG008
Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks)
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
All events were treatment emergent during the LY2189265 treatment period.
9
62
55
62
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG0030 events0 affected141 at risk
EG0040 events0 affected280 at risk
EG0050 events0 affected279 at risk
EG0060 events0 affected278 at risk
EG0071 events1 affected62 at risk
EG0080 events0 affected62 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 15.0
Systematic Assessment
Event resulted in one death in the 1.5 mg LY2189265 group
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0012 events2 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Gastrooesophageal sphincter insufficiency
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Umbilical hernia, obstructive
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Chest pain
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Death
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Gait disturbance
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Thrombosis in device
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Abscess
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0003 events3 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Gangrene
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Human anaplasmosis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Localised infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0002 events2 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Renal abscess
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0022 events2 affected278 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0022 events2 affected278 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Gastrointestinal stromal tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Liposarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected168 at risk
EG0010 events0 affected163 at risk
EG0020 events0 affected157 at risk
EG003
Prostate cancer stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected168 at risk
EG0010 events0 affected163 at risk
EG0020 events0 affected157 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Syncope
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Impaired self-care
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Bladder perforation
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0011 events1 affected279 at risk
EG0021 events1 affected278 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected116 at risk
EG0020 events0 affected121 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Rehabilitation therapy
Surgical and medical procedures
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected280 at risk
EG0010 events0 affected279 at risk
EG0020 events0 affected278 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0006 events5 affected280 at risk
EG00115 events12 affected279 at risk
EG0026 events5 affected278 at risk
EG0032 events2 affected141 at risk
EG0046 events5 affected280 at risk
EG00519 events16 affected279 at risk
EG0066 events5 affected278 at risk
EG0072 events2 affected62 at risk
EG0086 events4 affected62 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG00042 events22 affected280 at risk
EG00155 events31 affected279 at risk
EG00222 events16 affected278 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0006 events5 affected280 at risk
EG00136 events22 affected279 at risk
EG00219 events19 affected278 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0004 events3 affected280 at risk
EG00115 events14 affected279 at risk
EG0027 events6 affected278 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG00060 events45 affected280 at risk
EG001108 events78 affected279 at risk
EG00286 events71 affected278 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG00029 events17 affected280 at risk
EG00167 events47 affected279 at risk
EG00240 events30 affected278 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Systematic Assessment
EG00016 events12 affected280 at risk
EG00111 events10 affected279 at risk
EG00221 events21 affected278 at risk
EG003
Oedema peripheral
General disorders
MedDRA 15.0
Systematic Assessment
EG00013 events13 affected280 at risk
EG0013 events3 affected279 at risk
EG00212 events11 affected278 at risk
EG003
Influenza
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0008 events8 affected280 at risk
EG0015 events5 affected279 at risk
EG0028 events7 affected278 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG00026 events23 affected280 at risk
EG00119 events18 affected279 at risk
EG00212 events12 affected278 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0006 events6 affected280 at risk
EG0015 events5 affected279 at risk
EG00210 events10 affected278 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG00017 events14 affected280 at risk
EG00113 events12 affected279 at risk
EG00214 events12 affected278 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0008 events8 affected280 at risk
EG00111 events11 affected279 at risk
EG0026 events6 affected278 at risk
EG003
Lipase increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0003 events3 affected280 at risk
EG0018 events7 affected279 at risk
EG0026 events5 affected278 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG00014 events14 affected280 at risk
EG00123 events22 affected279 at risk
EG0028 events8 affected278 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG00010 events10 affected280 at risk
EG0019 events8 affected279 at risk
EG00212 events9 affected278 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG00010 events9 affected280 at risk
EG00111 events11 affected279 at risk
EG0029 events8 affected278 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0009 events8 affected280 at risk
EG0016 events6 affected279 at risk
EG0028 events8 affected278 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0009 events8 affected280 at risk
EG00119 events15 affected279 at risk
EG00223 events18 affected278 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG00010 events9 affected280 at risk
EG00126 events20 affected279 at risk
EG00227 events24 affected278 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0004 events4 affected280 at risk
EG0015 events5 affected279 at risk
EG0023 events3 affected278 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0006 events6 affected280 at risk
EG0017 events7 affected279 at risk
EG0023 events3 affected278 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
D000077270
Exenatide
D008687
Metformin
D000077205
Pioglitazone
Ancestor Terms
ID
Term
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D014688
Venoms
D045424
Complex Mixtures
D014118
Toxins, Biological
D001685
Biological Factors
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
D009930
Organic Chemicals
D045162
Thiazolidinediones
D013844
Thiazoles
D013457
Sulfur Compounds
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
54.56
± 10.01
BG00455.65± 9.81
120
BG00358
BG004406
Male
BG000163
BG001168
BG002156
BG00383
BG004570
91
BG00345
BG004331
Not Hispanic or Latino
BG000186
BG001178
BG002184
BG00396
BG004644
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0041
38
BG00320
BG004135
Asian
BG0006
BG0018
BG0024
BG0036
BG00424
Native Hawaiian or Other Pacific Islander
BG0001
BG0011
BG0021
BG0030
BG0043
Black or African American
BG00024
BG00124
BG00218
BG00310
BG00476
White
BG000205
BG001207
BG002211
BG003103
BG004726
More than one race
BG0003
BG0013
BG0023
BG0032
BG00411
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0041
223
BG003113
BG004788
Mexico
Title
Measurements
BG00037
BG00136
BG00235
BG00319
BG004127
Argentina
Title
Measurements
BG00016
BG00118
BG00218
BG0039
BG00461
97.37
± 18.87
BG00394.12± 19.28
BG00496.04± 19.64
BG00233.54± 5.36
BG00332.90± 5.66
BG00433.16± 5.43
8.07
± 1.34
BG0038.06± 1.31
BG0048.07± 1.31
8.84
± 5.71
BG0038.60± 5.78
BG0048.76± 5.61
9.11
± 3.04
BG0039.22± 3.01
BG0049.02± 2.97
119
-0.46
± 0.08
OG000
OG002
Non-inferiority analysis.
ANCOVA
<0.0001
P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.52
2-Sided
95
-0.66
-0.39
Yes
Non-Inferiority or Equivalence
A non-inferiority margin of 0.4% was used.
OG001
OG003
Superiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.84
2-Sided
95
-1.01
-0.67
No
Superiority or Other
OG000
OG002
Superiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.52
2-Sided
95
-0.66
-0.39
No
Superiority or Other
OG001
OG002
Non-inferiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.31
2-Sided
95
-0.44
-0.18
Yes
Non-Inferiority or Equivalence
A non-inferiority margin of 0.4% was used.
OG001
OG002
Superiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.31
2-Sided
95
-0.44
-0.18
No
Superiority or Other
Units
Counts
Participants
OG000271
OG001269
OG002266
Title
Denominators
Categories
Title
Measurements
OG000-1.36± 0.08
OG001-1.07± 0.08
OG002-0.80± 0.08
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Non-inferiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.56
2-Sided
95
-0.73
-0.39
Yes
Non-Inferiority or Equivalence
A non-inferiority margin of 0.4% was used.
OG001
OG002
Non-inferiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.27
2-Sided
95
-0.44
-0.11
Yes
Non-Inferiority or Equivalence
A non-inferiority margin of 0.4% was used.
OG000
OG002
Superiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.56
2-Sided
95
-0.73
-0.39
No
Superiority or Other
OG001
OG002
Superiority analysis.
ANCOVA
<0.001
P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.
LS Mean Difference
-0.27
2-Sided
95
-0.44
-0.11
No
Superiority or Other
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000259
OG001253
OG002245
OG003109
Title
Denominators
Categories
Title
Measurements
OG000-1.34± 0.25
OG0010.18± 0.25
OG002-1.14± 0.26
OG0031.37± 0.37
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
OG003
Mixed Models Analysis
<0.001
LS Mean Difference
-2.72
2-Sided
95
-3.58
-1.85
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.571
LS Mean Difference
-0.20
2-Sided
95
-0.88
0.49
No
Superiority or Other
OG001
OG003
Mixed Models Analysis
0.007
LS Mean Difference
-1.19
2-Sided
95
-2.06
-0.33
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
<0.001
LS Mean Difference
1.33
2-Sided
95
0.64
2.01
No
Superiority or Other
OG002
OG003
Mixed Models Analysis
<0.001
LS Mean Difference
-2.52
2-Sided
95
-3.39
-1.65
No
Superiority or Other
Units
Counts
Participants
OG000238
OG001231
OG002210
Title
Denominators
Categories
Title
Measurements
OG000-1.08± 0.34
OG0010.49± 0.34
OG002-0.76± 0.35
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mixed Models Analysis
0.507
LS Mean Difference
-0.32
2-Sided
95
-1.25
0.62
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.009
LS Mean Difference
1.25
2-Sided
95
0.32
2.19
No
Superiority or Other
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000259
OG001253
OG002245
OG003109
Title
Denominators
Categories
Title
Measurements
OG000-0.48± 0.09
OG0010.07± 0.09
OG002-0.41± 0.09
OG0030.49± 0.13
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
OG003
Mixed Models Analysis
<0.001
LS Means Difference
-0.97
2-Sided
95
-1.27
-0.67
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.568
LS Mean Difference
-0.07
2-Sided
95
-0.31
0.17
No
Superiority or Other
OG001
OG003
Mixed Models Analysis
0.006
LS Mean Difference
-0.42
2-Sided
95
-0.72
-0.12
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
<0.001
LS Mean Difference
0.48
2-Sided
95
0.24
0.71
No
Superiority or Other
OG002
OG003
Mixed Models Analysis
<0.001
LS Mean Difference
-0.90
2-Sided
95
-1.20
-0.60
No
Superiority or Other
Units
Counts
Participants
OG000238
OG001231
OG002210
Title
Denominators
Categories
Title
Measurements
OG000-0.37± 0.12
OG0010.18± 0.12
OG002-0.28± 0.12
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mixed Models Analysis
0.580
LS Mean Difference
-0.09
2-Sided
95
-0.42
0.23
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.005
LS Mean Difference
0.46
2-Sided
95
0.14
0.79
No
Superiority or Other
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000207
OG001195
OG002202
OG00378
Title
Denominators
Categories
Title
Measurements
OG000-46.82± 1.81
OG001-42.09± 1.87
OG002-37.48± 1.83
OG003-18.07± 2.68
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
OG003
Mixed Models Analysis
<0.001
LS Mean Difference
-28.76
2-Sided
95
-34.50
-23.02
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean Difference
-9.34
2-Sided
95
-13.62
-5.06
No
Superiority or Other
OG001
OG003
Mixed Models Analysis
<0.001
LS Mean Difference
-24.02
2-Sided
95
-29.80
-18.24
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.038
LS Mean Difference
-4.61
2-Sided
95
-8.95
-0.27
No
Superiority or Other
OG002
OG003
Mixed Models Analysis
<0.001
LS Mean Difference
-19.41
2-Sided
95
-25.18
-13.65
No
Superiority or Other
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000187
OG001185
OG002178
Title
Denominators
Categories
Title
Measurements
OG000-43.84± 2.07
OG001-40.62± 2.12
OG002-36.16± 2.11
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mixed Models Analysis
0.004
LS Mean Difference
-7.68
2-Sided
95
-12.84
-2.52
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.092
LS Mean Difference
-4.47
2-Sided
95
-9.66
0.73
No
Superiority or Other
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000271
OG001269
OG002266
OG003119
Title
Denominators
Categories
HbA1c Less Than 7%
Title
Measurements
OG00078.2
OG00165.8
OG00252.3
OG00342.9
HbA1c Less Than or Equal to 6.5%
Title
Measurements
OG00062.7
OG00153.2
OG00238.0
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
OG003
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than 7.0%.
Odds Ratio (OR)
13.1
2-Sided
95
7.4
23.4
No
Superiority or Other
OG000
OG002
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than 7.0%.
Odds Ratio (OR)
6.2
2-Sided
95
3.9
10.1
No
Superiority or Other
OG001
OG003
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than 7.0%.
Odds Ratio (OR)
4.8
2-Sided
95
2.8
8.0
No
Superiority or Other
OG001
OG002
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than 7.0%.
Odds Ratio (OR)
2.3
2-Sided
95
1.5
3.5
No
Superiority or Other
OG002
OG003
Regression, Logistic
0.004
Treatment comparison for HbA1c less than 7.0%.
Odds Ratio (OR)
2.1
2-Sided
95
1.3
3.5
No
Superiority or Other
OG000
OG003
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than or equal to 6.5%.
Odds Ratio (OR)
11.8
2-Sided
95
6.7
20.8
No
Superiority or Other
OG000
OG002
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than or equal to 6.5%.
Odds Ratio (OR)
4.4
2-Sided
95
2.9
6.8
No
Superiority or Other
OG001
OG003
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than or equal to 6.5%.
Odds Ratio (OR)
6.3
2-Sided
95
3.7
10.9
No
Superiority or Other
OG001
OG002
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than or equal to 6.5%.
Odds Ratio (OR)
2.4
2-Sided
95
1.6
3.5
No
Superiority or Other
OG002
OG003
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than or equal to 6.5%.
Odds Ratio (OR)
2.7
2-Sided
95
1.6
4.6
No
Superiority or Other
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000271
OG001269
OG002266
Title
Denominators
Categories
HbA1c Less Than 7.0%
Title
Measurements
OG00070.8
OG00159.1
OG00249.2
HbA1c Less Than or Equal to 6.5%
Title
Measurements
OG00057.2
OG00148.3
OG00234.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than 7.0%.
Odds Ratio (OR)
3.7
2-Sided
95
2.4
5.6
No
Superiority or Other
OG001
OG002
Regression, Logistic
0.008
Treatment comparison for HbA1c less than 7.0%.
Odds Ratio (OR)
1.7
2-Sided
95
1.1
2.5
No
Superiority or Other
OG000
OG002
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than or equal to 6.5%.
Odds Ratio (OR)
3.5
2-Sided
95
2.3
5.1
No
Superiority or Other
OG001
OG002
Regression, Logistic
<0.001
Treatment comparison for HbA1c less than or equal to 6.5%.
Odds Ratio (OR)
2.1
2-Sided
95
1.4
3.1
No
Superiority or Other
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000238
OG001218
OG002223
OG00398
Title
Denominators
Categories
HOMA2-%B
Title
Measurements
OG00036.14± 2.60
OG00123.61± 2.67
OG00215.02± 2.62
OG0030.93± 3.66
HOMA2-%S
Title
Measurements
OG000-3.14± 2.91
OG0011.16± 2.97
OG002-1.59± 2.92
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
OG003
Mixed Models Analysis
<0.001
Treatment comparison of HOMA2-B
LS Mean Difference
35.21
2-Sided
95
27.26
43.16
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
<0.001
Treatment comparison of HOMA2-B
LS Mean Difference
21.12
2-Sided
95
14.97
27.28
No
Superiority or Other
OG001
OG003
Mixed Models Analysis
<0.001
Treatment comparison of HOMA2-B
LS Mean Difference
22.68
2-Sided
95
14.63
30.72
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.007
Treatment comparison of HOMA2-B
LS Mean Difference
8.59
2-Sided
95
2.31
14.87
No
Superiority or Other
OG002
OG003
Mixed Models Analysis
<0.001
Treatment comparison of HOMA2-B
LS Mean Difference
14.09
2-Sided
95
6.06
22.11
No
Superiority or Other
OG000
OG003
Mixed Models Analysis
0.207
Treatment comparison of HOMA2-S
LS Mean Difference
-5.70
2-Sided
95
-14.56
3.17
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.659
Treatment comparison of HOMA2-S
LS Mean Difference
-1.54
2-Sided
95
-8.41
5.32
No
Superiority or Other
OG001
OG003
Mixed Models Analysis
0.759
Treatment comparison of HOMA2-S
LS Mean Difference
-1.40
2-Sided
95
-10.37
7.56
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.441
Treatment comparison of HOMA2-S
LS Mean Difference
2.75
2-Sided
95
-4.25
9.76
No
Superiority or Other
OG002
OG003
Mixed Models Analysis
0.362
Treatment comparison of HOMA2-S
LS Mean Difference
-4.15
2-Sided
95
-13.10
4.79
No
Superiority or Other
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000219
OG001202
OG002187
Title
Denominators
Categories
HOMA2-%B
Title
Measurements
OG00035.21± 2.63
OG00125.69± 2.70
OG00213.57± 2.75
HOMA2-%S
Title
Measurements
OG000-7.48± 2.93
OG001-5.49± 3.01
OG002-3.75± 3.07
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mixed Models Analysis
<0.001
Treatment comparison of HOMA2-B
LS Mean Difference
21.64
2-Sided
95
15.20
28.08
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
<0.001
Treatment comparison of HOMA2-B
LS Mean Difference
12.12
2-Sided
95
5.56
18.68
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.307
Treatment comparison of HOMA2-S
LS Mean Difference
-3.73
2-Sided
95
-10.90
3.43
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.638
Treatment comparison of HOMA2-S
LS Mean Difference
-1.75
2-Sided
95
-9.05
5.55
No
Superiority or Other
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
VAS Health State Score (n=270, 267, 264, 119)
Title
Measurements
OG0004.50± 0.85
OG0012.41± 0.85
OG0023.94± 0.85
OG0030.71± 1.15
EQ-5D UK (n=270, 266, 264, 119)
Title
Measurements
OG0000.01± 0.01
OG0010.01± 0.01
OG0020.00± 0.01
OG003
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
VAS Health State Score (n=270, 267, 264)
Title
Measurements
OG0005.15± 0.89
OG0013.52± 0.89
OG0023.51± 0.89
EQ-5D UK (n=270, 266, 264)
Title
Measurements
OG0000.02± 0.01
OG0010.01± 0.01
OG002-0.00± 0.01
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000270
OG001268
OG002266
OG003119
Title
Denominators
Categories
Title
Measurements
OG0002.40± 0.34
OG0012.56± 0.33
OG0020.85± 0.33
OG0030.49± 0.45
OG001
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
DTSQs Treatment Satisfaction (n=270, 268, 266)
Title
Measurements
OG0002.05± 0.36
OG0012.11± 0.36
OG0020.69± 0.36
DTSQc Treatment Satisfaction (n=249, 237, 226)
Title
Measurements
OG00015.36± 0.40
OG00115.46± 0.41
OG00214.01± 0.41
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000270
OG001267
OG002266
OG003119
Title
Denominators
Categories
Title
Measurements
OG0000.18± 0.27
OG0010.12± 0.27
OG0020.47± 0.27
OG0030.03± 0.36
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000270
OG001267
OG002266
Title
Denominators
Categories
Title
Measurements
OG0000.18± 0.29
OG001-0.18± 0.29
OG0020.35± 0.29
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000270
OG001267
OG002266
OG003119
Title
Denominators
Categories
Title
Measurements
OG0000.56± 0.15
OG0010.47± 0.15
OG0020.46± 0.15
OG0030.45± 0.20
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000270
OG001267
OG002266
Title
Denominators
Categories
Title
Measurements
OG0000.50± 0.15
OG0010.47± 0.15
OG0020.64± 0.15
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
Any CV Event
Title
Measurements
OG0003
OG0012
OG0022
Any Fatal Event
Title
Measurements
OG0001
OG0010
OG0020
Any Non-fatal CV Event
Title
Measurements
OG0003
OG0012
OG0022
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
QTcF Interval (n=253, 260, 250, 120)
Title
Measurements
OG000-1.11± 1.00
OG0010.91± 0.99
OG0021.21± 1.00
OG0031.32± 1.33
PR Interval (n=252, 259, 246, 116)
Title
Measurements
OG0002.35± 0.89
OG0010.93± 0.88
OG0021.01± 0.89
OG003
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
QTcF Interval (n=239, 243, 226)
Title
Measurements
OG0001.28± 1.07
OG0012.30± 1.07
OG0022.52± 1.10
PR Interval (n=237, 243, 220)
Title
Measurements
OG0002.57± 0.96
OG0010.69± 0.96
OG002-0.82± 0.99
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000263
OG001266
OG002259
OG003127
Title
Denominators
Categories
Title
Measurements
OG0002.80± 0.52
OG0012.80± 0.51
OG0021.18± 0.52
OG0030.61± 0.70
Units
Counts
Participants
OG000248
OG001256
OG002238
Title
Denominators
Categories
Title
Measurements
OG0001.68± 0.56
OG0011.56± 0.55
OG0021.15± 0.56
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Seated SBP (n=263, 266, 259, 127)
Title
Measurements
OG0000.11± 0.83
OG001-0.36± 0.82
OG0020.06± 0.83
OG0033.40± 1.13
Seated DBP (n=263, 266, 259, 127)
Title
Measurements
OG0000.76± 0.55
OG0010.56± 0.54
OG002-0.11± 0.55
OG003
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
Seated SBP (n=248, 256, 238)
Title
Measurements
OG0000.83± 0.87
OG0011.62± 0.85
OG0020.02± 0.88
Seated DBP (n=248, 256, 238)
Title
Measurements
OG0000.89± 0.57
OG0010.76± 0.57
OG0020.02± 0.58
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo/1.5 mg LY2189265
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG004
Placebo/0.75 mg LY2189265
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG00362
OG00462
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Amylase, Total (n=253, 253, 254, 127)
Title
Measurements
OG00012.50± 26.55(-3.57 to 28.85)
OG0013.28± 24.24(-9.88 to 20.00)
OG0025.56± 26.61(-9.52 to 18.46)
OG003-3.33± 27.51(-15.79 to 11.36)
Amylase, Pancreas-derived (n=237, 247, 246, 122)
Title
Measurements
OG00014.81(0.00 to 35.00)
OG00110.34(-5.88 to 26.67)
OG0025.56(-7.14 to 21.05)
OG003
Lipase (n=198, 203, 222, 114)
Title
Measurements
OG00010.34(-7.50 to 29.41)
OG0010.00(-15.91 to 23.08)
OG0023.94(-10.26 to 23.08)
OG003
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
Amylase, Total (n=255, 263, 261)
Title
Measurements
OG0009.21(-4.95 to 23.19)
OG0012.78(-11.67 to 17.50)
OG0022.38(-11.86 to 15.22)
Amylase, Pancreas-derived (n=236, 253, 246)
Title
Measurements
OG00016.67(0.00 to 35.60)
OG0017.69(-8.70 to 28.00)
OG0027.85(-8.82 to 26.67)
Lipase (n=201, 205, 221)
Title
Measurements
OG0005.45(-7.69 to 26.92)
OG0010.00(-18.18 to 15.63)
OG0023.57(-13.95 to 22.58)
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000275
OG001277
OG002272
OG003139
Title
Denominators
Categories
Title
Measurements
OG0000.20± 1.20
OG0010.22± 1.91
OG0020.05± 1.48
OG0030.05± 0.89
Units
Counts
Participants
OG000275
OG001277
OG002272
Title
Denominators
Categories
Title
Measurements
OG0000.21± 1.29
OG0010.05± 1.79
OG0020.10± 1.67
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Severe HE
Title
Measurements
OG0000
OG0010
OG0021
OG0030
Documented Symptomatic HE
Title
Measurements
OG00031
OG00125
OG002146
OG003
Asymptomatic HE
Title
Measurements
OG00026
OG00195
OG00251
OG003
Nocturnal HE
Title
Measurements
OG0009
OG00115
OG00231
OG003
Probable Symptomatic HE
Title
Measurements
OG0005
OG00116
OG0023
OG003
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
Severe HE
Title
Measurements
OG0000
OG0010
OG0022
Documented Symptomatic HE
Title
Measurements
OG00053
OG00139
OG002205
Asymptomatic HE
Title
Measurements
OG00047
OG001157
OG00298
Nocturnal HE
Title
Measurements
OG00020
OG00129
OG00257
Probable Symptomatic HE
Title
Measurements
OG0008
OG00122
OG0024
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Severe HE
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.01± 0.12
OG0030.00± 0.00
Documented symptomatic HE
Title
Measurements
OG0000.22± 1.94
OG0010.18± 0.97
OG0021.07± 4.90
OG003
Asymptomatic HE
Title
Measurements
OG0000.19± 1.13
OG0010.69± 4.74
OG0020.38± 1.74
OG003
Nocturnal HE
Title
Measurements
OG0000.06± 0.60
OG0010.19± 1.74
OG0020.23± 1.16
OG003
Probable symptomatic HE
Title
Measurements
OG0000.04± 0.37
OG0010.24± 2.44
OG0020.02± 0.21
OG003
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
Severe HE
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.01± 0.09
Documented symptomatic HE
Title
Measurements
OG0000.19± 1.23
OG0010.14± 0.78
OG0020.76± 3.18
Asymptomatic HE
Title
Measurements
OG0000.17± 1.05
OG0010.56± 3.57
OG0020.37± 1.81
Nocturnal HE
Title
Measurements
OG0000.07± 0.63
OG0010.19± 1.72
OG0020.21± 1.06
Probable symptomatic HE
Title
Measurements
OG0000.03± 0.26
OG0010.21± 2.38
OG0020.02± 0.16
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Title
Measurements
OG0004
OG00114
OG00213
OG00322
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
Title
Measurements
OG00010
OG00127
OG00231
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000559
OG001276
OG002141
Title
Denominators
Categories
Title
Measurements
OG0006
OG00112
OG0022
OG002
Placebo/0.75 mg LY2189265 or 1.5 mg LY2189265
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000552
OG001270
OG002123
Title
Denominators
Categories
52 weeks
Title
Measurements
OG0003
OG0012
OG0022
4 weeks after last study dose
Title
Measurements
OG0001
OG0010
OG0021
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Title
Measurements
OG000215
OG001199
OG002198
OG003104
OG002
Exenatide
Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG003
Placebo/1.5 mg LY2189265
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
OG004
Placebo/0.75 mg LY2189265
Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG00362
OG00462
Title
Denominators
Categories
Title
Measurements
OG000226
OG001220
OG002221
OG00347
OG00441
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks
Units
Counts
Participants
OG000279
OG001280
OG002276
OG003141
Title
Denominators
Categories
Title
Measurements
OG000NA± NANo clinically relevant changes from baseline to 26 weeks in hematological and biochemical laboratory values were noted, with the exception of pancreatic enzymes and calcitonin measures, which are reported in separate outcome measures.
OG001NA± NANo clinically relevant changes from baseline to 26 weeks in hematological and biochemical laboratory values were noted, with the exception of pancreatic enzymes and calcitonin measures, which are reported in separate outcome measures.
OG002NA± NANo clinically relevant changes from baseline to 26 weeks in hematological and biochemical laboratory values were noted, with the exception of pancreatic enzymes and calcitonin measures, which are reported in separate outcome measures.
OG003NA± NANo clinically relevant changes from baseline to 26 weeks in hematological and biochemical laboratory values were noted, with the exception of pancreatic enzymes and calcitonin measures, which are reported in separate outcome measures.
Units
Counts
Participants
OG000279
OG001280
OG002276
Title
Denominators
Categories
Title
Measurements
OG000NA± NANo clinically relevant changes from baseline to 26 weeks in hematological and biochemical laboratory values were noted, with the exception of pancreatic enzymes and calcitonin measures, which are reported in separate outcome measures.
OG001NA± NANo clinically relevant changes from baseline to 26 weeks in hematological and biochemical laboratory values were noted, with the exception of pancreatic enzymes and calcitonin measures, which are reported in separate outcome measures.
OG002NA± NANo clinically relevant changes from baseline to 26 weeks in hematological and biochemical laboratory values were noted, with the exception of pancreatic enzymes and calcitonin measures, which are reported in separate outcome measures.
OG003
Placebo
Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks