Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
978 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-02-28
Study Completion Date
2012-05-31
Brief Summary
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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.
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Detailed Description
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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
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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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
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Pioglitazone
Intervention Type
DRUG
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
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Pioglitazone
Intervention Type
DRUG
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
Group Type
ACTIVE_COMPARATOR
Exenatide
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Pioglitazone
Intervention Type
DRUG
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
Group Type
PLACEBO_COMPARATOR
LY2189265
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Pioglitazone
Intervention Type
DRUG
Interventions
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LY2189265
Intervention Type
DRUG
Exenatide
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Pioglitazone
Intervention Type
DRUG
Other Intervention Names
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Dulaglutide
Eligibility Criteria
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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.
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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Goodyear, Arizona, United States
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Phoenix, Arizona, United States
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Cathedral City, California, United States
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Concord, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Lancaster, California, United States
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Mission Hills, California, United States
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Monterey, California, United States
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National City, California, United States
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Oceanside, California, United States
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Paramount, California, United States
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Roseville, California, United States
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San Ramon, California, United States
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Tustin, California, United States
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New Britain, Connecticut, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Meridian, Idaho, United States
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Crystal Lake, Illinois, United States
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Peoria, Illinois, United States
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Vincennes, Indiana, United States
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Topeka, Kansas, United States
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Madisonville, Kentucky, United States
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New Orleans, Louisiana, United States
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Bangor, Maine, United States
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Biddeford, Maine, United States
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Elkridge, Maryland, United States
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Bloomfield Hills, Michigan, United States
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Flint, Michigan, United States
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St Louis, Missouri, United States
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Nashua, New Hampshire, United States
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Toms River, New Jersey, United States
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Albany, New York, United States
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Flushing, New York, United States
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Syracuse, New York, United States
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Asheville, North Carolina, United States
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Cary, North Carolina, United States
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Durham, North Carolina, United States
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Morehead City, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Delaware, Ohio, United States
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Perrysburg, Ohio, United States
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Bend, Oregon, United States
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Corvallis, Oregon, United States
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Eugene, Oregon, United States
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Beaver, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wilkes-Barre, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Memphis, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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San Antonio, Texas, United States
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Schertz, Texas, United States
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Ogden, Utah, United States
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St. George, Utah, United States
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West Jordan, Utah, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Buenos Aires, , Argentina
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Caguas, , Puerto Rico
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Hato Rey, , Puerto Rico
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ManatÃ, , Puerto Rico
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Ponce, , Puerto Rico
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San Germán, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Yabucoa, , Puerto Rico
Site Status
Countries
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United States
Argentina
Mexico
Puerto Rico
References
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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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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H9X-MC-GBDA
Identifier Type: OTHER
Identifier Source: secondary_id
11373
Identifier Type: -
Identifier Source: org_study_id
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