Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2013
End Date:December 2014

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A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)

The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide
compared to placebo in participants with type 2 diabetes who have inadequate glycemic
control with sulfonylurea monotherapy.


Inclusion Criteria:

- Type 2 diabetes mellitus

- Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the
local label for at least 3 months prior to the first study visit

- Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw
performed at the first study visit

- Accept continued treatment with sulfonylurea therapy, 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 per square meter (kg/m^2)

Exclusion Criteria:

- Have type 1 diabetes mellitus

- Have been treated with ANY other antihyperglycemic medications (other than
sulfonylurea) at the time of the first study visit or within 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 within 3 months prior to the first study visit is exclusionary

- Have been treated with drugs that promote weight loss within 3 months prior to 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 >2.5 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 an estimated glomerular filtration rate [eGFR] <30 milliliter per minute per
1.73 square meter (mL/min/1.73 m^2), calculated using the Chronic Kidney Disease
Epidemiology Collaboration [CKD-EPI] equation as determined by the central laboratory
at the first study visit

- 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 per milliliter (pg/mL) as determined by the
central laboratory at the first study visit
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