A Study in Participants With Type 2 Diabetes Mellitus (AWARD-1)

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)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: LY2189265; Drug: Placebo; Drug: Metformin; Drug: Pioglitazone; Drug: Exenatide

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.

• Study Type: Interventional
• Enrollment (Actual): 978
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, CBA 1419
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• Mexico
  • Guadalajara, Mexico, 44600
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  • Mexico City, Mexico, 6700
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  • Monterrey, Mexico, 64461
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• Puerto Rico
  • Caguas, Puerto Rico, 00726
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  • Hato Rey, Puerto Rico, 00917
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  • Manati, Puerto Rico, 00674
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  • Ponce, Puerto Rico, 00716
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  • San German, Puerto Rico, 00683
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  • San Juan, Puerto Rico, 00907
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  • Yabucoa, Puerto Rico, 00767
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• United States
  • Arizona
    • Goodyear, Arizona, United States, 85395
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    • Phoenix, Arizona, United States, 85028
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  • California
    • Cathedral City, California, United States, 92234
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    • Concord, California, United States, 94520
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    • Fresno, California, United States, 93720
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    • Greenbrae, California, United States, 94904
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    • Lancaster, California, United States, 93534
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    • Mission Hills, California, United States, 91345
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    • Monterey, California, United States, 93940
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    • National City, California, United States, 91950
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    • Oceanside, California, United States, 92056
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    • Paramount, California, United States, 90723
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    • Roseville, California, United States, 95661
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    • San Ramon, California, United States, 94583
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    • Tustin, California, United States, 92780
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  • Connecticut
    • New Britain, Connecticut, United States, 06050
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  • Florida
    • Fort Lauderdale, Florida, United States, 33316
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    • Hollywood, Florida, United States, 33021
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    • Orlando, Florida, United States, 32806
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    • Pembroke Pines, Florida, United States, 33027
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    • West Palm Beach, Florida, United States, 33401
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  • Georgia
    • Atlanta, Georgia, United States, 30308
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  • Hawaii
    • Honolulu, Hawaii, United States, 96813
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  • Idaho
    • Boise, Idaho, United States, 83702
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    • Idaho Falls, Idaho, United States, 83404
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    • Meridian, Idaho, United States, 83646
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  • Illinois
    • Crystal Lake, Illinois, United States, 60012
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    • Peoria, Illinois, United States, 61615
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  • Indiana
    • Vincennes, Indiana, United States, 47591
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  • Kansas
    • Topeka, Kansas, United States, 66606
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  • Kentucky
    • Madisonville, Kentucky, United States, 42431
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  • Louisiana
    • New Orleans, Louisiana, United States, 70112
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  • Maine
    • Bangor, Maine, United States, 04401
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    • Biddeford, Maine, United States, 04005
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  • Maryland
    • Elkridge, Maryland, United States, 21075
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  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
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    • Flint, Michigan, United States, 48503
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  • Missouri
    • St Louis, Missouri, United States, 63141
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  • New Hampshire
    • Nashua, New Hampshire, United States, 03063
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  • New Jersey
    • Toms River, New Jersey, United States, 08753
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  • New York
    • Albany, New York, United States, 12206
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    • Flushing, New York, United States, 11365
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    • Syracuse, New York, United States, 13210
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  • North Carolina
    • Asheville, North Carolina, United States, 28803
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    • Cary, North Carolina, United States, 27518
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    • Durham, North Carolina, United States, 27713
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    • Morehead City, North Carolina, United States, 28557
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  • Ohio
    • Cincinnati, Ohio, United States, 45242
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    • Cleveland, Ohio, United States, 44122
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    • Columbus, Ohio, United States, 43210
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    • Dayton, Ohio, United States, 45439
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    • Delaware, Ohio, United States, 43015
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    • Perrysburg, Ohio, United States, 43551
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  • Oregon
    • Bend, Oregon, United States, 97701
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    • Corvallis, Oregon, United States, 97330
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    • Eugene, Oregon, United States, 97401
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  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
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    • Danville, Pennsylvania, United States, 17822
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    • Levittown, Pennsylvania, United States, 19056
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    • Philadelphia, Pennsylvania, United States, 19107
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    • Wilkes Barre, Pennsylvania, United States, 18711
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  • South Carolina
    • Charleston, South Carolina, United States, 29412
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    • Greenville, South Carolina, United States, 29605
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    • Greer, South Carolina, United States, 29651
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    • Myrtle Beach, South Carolina, United States, 29572
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  • Tennessee
    • Memphis, Tennessee, United States, 38119
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  • Texas
    • Arlington, Texas, United States, 76014
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    • Austin, Texas, United States, 78731
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    • Corpus Christi, Texas, United States, 78404
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    • Dallas, Texas, United States, 75231
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    • El Paso, Texas, United States, 79925
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    • San Antonio, Texas, United States, 78258
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    • Schertz, Texas, United States, 78154
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  • Utah
    • Ogden, Utah, United States, 84403
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    • St. George, Utah, United States, 84790
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    • West Jordan, Utah, United States, 84088
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  • Washington
    • Spokane, Washington, United States, 99202
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    • Tacoma, Washington, United States, 98405
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications

  1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: LY2189265; Other Names: Dulaglutide; Drug: Metformin; Drug: Pioglitazone
Experimental: 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	Drug: LY2189265; Other Names: Dulaglutide; Drug: Metformin; Drug: Pioglitazone
Active Comparator: 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	Drug: Metformin; Drug: Pioglitazone; Drug: Exenatide
Placebo Comparator: Placebo; 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	Drug: LY2189265; Other Names: Dulaglutide; Drug: Placebo; Drug: Metformin; Drug: Pioglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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 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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 5, 2010
• First Submitted That Met QC Criteria: February 5, 2010
• First Posted (Estimate): February 8, 2010

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 15, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Dulaglutide; Metformin; Pioglitazone; Exenatide
• Other Study ID Numbers: 11373; H9X-MC-GBDA (Other Identifier: Eli Lilly and Company)