A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes (AWARD-6)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Liraglutide; Drug: Metformin; Drug: LY2189265

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624259

2011-003810-18 (EudraCT Number)

H9X-MC-GBDE (Other Identifier)

11377

Details and patient eligibility

About

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.

Enrollment: 599 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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599 participants in 2 patient groups

1.5 mg LY2189265

Experimental group

Description:

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks

Treatment:

Drug: LY2189265

Drug: Metformin

Liraglutide

Active Comparator group

Description:

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

Treatment:

Drug: Liraglutide

Drug: Metformin