A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes (AWARD-CHN3)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Insulin Glargine; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04591626

17731

H9X-MC-GBGO (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and efficacy of once weekly dulaglutide when added to insulin glargine, with metformin and/or acarbose in Chinese participants with type 2 diabetes mellitus.

Enrollment: 291 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have type 2 diabetes
• are men or nonpregnant women aged ≥18 years at screening
• have been treated with basal insulin glargine once daily and metformin and/or acarbose for at least 3 months prior to screening
• doses of once daily insulin glargine and OAMs must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±20% of the most commonly used insulin glargine dose during this same period. Doses of metformin and/or acarbose are considered stable when doses are unchanged during the same period, and the doses should be in the inclusive range of the half maximum to maximum approved daily dose per the locally-approved label
• have an HbA1c value ≥7.0% and ≤11.0% as assessed by the central laboratory at screening
• require further insulin glargine dose increase at baseline per the TTT algorithm based on the SMBG data (FBG ≥5.6mmol/L) collected during the prior week
• have stable weight (±5%) ≥3 months prior to screening
• have body mass index (BMI) between ≥19.0 and ≤35.0 kg/m2 at screening

Exclusion criteria

• have type 1 diabetes (T1D)
• have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
• have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
• have had any of the following CV conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)
• have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone or plan to have a gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility
• have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening
• for participants on metformin or metformin and acarbose, have renal disease or renal dysfunction (eGFR [CKD-EPI] <45 mL/min/1.73 m2), as determined by the central laboratory; for participants on acarbose, have renal disease or renal dysfunction (eGFR [CKD-EPI] <25 mL/min/1.73 m2), as determined by the central laboratory
• have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) syndrome in the absence of known C-cell hyperplasia (the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B syndrome have a known RET mutation and the potential participant for the study is negative for the RET mutation)
• have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
• have serum calcitonin ≥20 pg/mL at screening, as determined by the central laboratory
• have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)
• have been treated with any other antihyperglycemia regimen, other than basal insulin glargine once daily and metformin and/or acarbose, within the 3 months prior to screening or between screening and baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 2 patient groups, including a placebo group

1.5 Milligrams (mg) Dulaglutide

Experimental group

Description:

Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose.

Treatment:

Drug: Dulaglutide

Drug: Insulin Glargine

Placebo

Placebo Comparator group

Description:

Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.

Treatment:

Drug: Insulin Glargine

Drug: Placebo