Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Dulaglutide; Glimepiride
Intervention description: Administered SQ; Administered SQ; Administered PO
Intervention MeSH terms: Glimepiride; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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