Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

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

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: 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

Relevance to patient case: not relevant