A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:June 2012
End Date:November 2013
Contact:There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559)
Phone:1-317-615-4559

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A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)


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.


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

- HbA1c value of ≥7.0% to ≤10.0%

- Accept continued treatment with metformin throughout the trial, as required per
protocol

- Men and nonpregnant women aged ≥18 years

- Stable weight (±5%) ≥3 months prior to screening

- Body Mass Index (BMI) ≤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 (>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 (CV) 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 (eg, 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 ≥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 ≥1.5 milligram/deciliter (mg/dL) (male) or ≥1.4 mg/dL
(female), or a creatinine clearance <60 milliliter/minute (mL/minute)

- Have any self or family history of type 2A or type 2B multiple endocrine neoplasia
(MEN 2A or 2B) 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,
carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)

- Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)
We found this trial at
11
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