study of how dulaglutide compares to placebo in participants with type 2 diabetes who are also on sulfonylurea therapy (award-8)

Conditions: Type 2 Diabetes Mellitus

Summary: 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.


Eligibility criteria:
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