A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes
NCT ID: NCT01624259
Last Updated: 2014-10-09
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
599 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-06-30
Study Completion Date
2013-11-30
Brief Summary
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The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
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Detailed Description
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Conditions
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Type 2 Diabetes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Administered SC
Metformin
Intervention Type
DRUG
Liraglutide
Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks
Group Type
ACTIVE_COMPARATOR
Liraglutide
Intervention Type
DRUG
Administered SC
Metformin
Intervention Type
DRUG
Interventions
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LY2189265
Administered SC
Intervention Type
DRUG
Liraglutide
Administered SC
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Other Intervention Names
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Dulaglutide
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit
* Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%
* Accept continued treatment with metformin throughout the trial, as required per protocol
* Men and nonpregnant women aged greater than or equal to 18 years
* Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening
* Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m\^2)
* Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit
* Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%
* Accept continued treatment with metformin throughout the trial, as required per protocol
* Men and nonpregnant women aged greater than or equal to 18 years
* Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening
* Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m\^2)
Exclusion Criteria
* Have type 1 diabetes mellitus
* Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit
* Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit
* Have been treated with drugs that promote weight loss within 3 months of the first study visit
* Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
* Have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident
* Have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal
* Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit
* Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)
* Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)
* Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
* Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)
* Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit
* Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit
* Have been treated with drugs that promote weight loss within 3 months of the first study visit
* Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
* Have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident
* Have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal
* Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit
* Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)
* Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)
* Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
* Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)
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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Phoenix, Arizona, United States
Site Status
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Chino, California, United States
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Fresno, California, United States
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Los Angeles, California, United States
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Spring Valley, California, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Oviedo, Florida, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Shreveport, Louisiana, United States
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Royal Oak, Michigan, United States
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Las Vegas, Nevada, United States
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Perrysburg, Ohio, United States
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Kingsport, Tennessee, United States
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Dallas, Texas, United States
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Hurst, Texas, United States
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San Antonio, Texas, United States
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Prague, , Czechia
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Dresden, , Germany
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Hohenmölsen, , Germany
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Lingen, , Germany
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Mainz, , Germany
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Neunkirchen, , Germany
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Saint Ingbert-Oberwürzbach, , Germany
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Sulzbach, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Dombóvár, , Hungary
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Székesfehérvár, , Hungary
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Monterrey, , Mexico
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Bialystok, , Poland
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Gdansk, , Poland
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Kamieniec Ząbkowicki, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Ruda Śląska, , Poland
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Szczecin, , Poland
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Tychy, , Poland
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Wroclaw, , Poland
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Hato Rey, , Puerto Rico
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Río Grande, , Puerto Rico
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Bucharest, , Romania
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Galati, , Romania
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Ploieşti, , Romania
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Sibiu, , Romania
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Košice, , Slovakia
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Malacky, , Slovakia
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Nitra, , Slovakia
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Nové Mesto nad Váhom, , Slovakia
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Alicante, , Spain
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Alzira, , Spain
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Barcelona, , Spain
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Centelles, , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
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Petrel, , Spain
Site Status
Countries
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United States
Czechia
Germany
Hungary
Mexico
Poland
Puerto Rico
Romania
Slovakia
Spain
References
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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
Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014 Oct 11;384(9951):1349-57. doi: 10.1016/S0140-6736(14)60976-4. Epub 2014 Jul 10.
Reference Type
DERIVED
Other Identifiers
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H9X-MC-GBDE
Identifier Type: OTHER
Identifier Source: secondary_id
2011-003810-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11377
Identifier Type: -
Identifier Source: org_study_id
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PHASE4
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PHASE3
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PHASE1
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PHASE1
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PHASE2
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PHASE1
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TERMINATED
PHASE2
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PHASE3
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COMPLETED
PHASE1
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PHASE2
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PHASE2
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PHASE2
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COMPLETED
PHASE3
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TERMINATED
PHASE2
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ACTIVE_NOT_RECRUITING
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COMPLETED
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