A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes (AWARD-JPN)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus (T2DM); Glucose Metabolism Disorders; Diabetes Mellitus; Metabolic Disease; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Endocrine System Diseases

Treatments: Drug: Oral antihyperglycemics; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04809220

H9X-JE-GBGQ (Other Identifier)

17779

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.

Enrollment: 591 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.

• Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.

• Have the following HbA1c result at screening.

  • Participants taking DPP-4i: ≥7.5% and ≤9.5%,
  • Participants taking another OAM: ≥8.0% and ≤10.0%

• Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks

• Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day 1.

Exclusion criteria

• Have type 1 diabetes (T1D)
• Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
• Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
• Have a known clinically significant gastric empty abnormality
• Have acute or chronic hepatitis
• Have had chronic or acute pancreatitis
• Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
• Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
• Have evidence of significant, active autoimmune abnormality
• Have evidence of significant, uncontrolled endocrine abnormality
• Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
• Have any hematologic condition that may interfere with HbA1c measurement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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591 participants in 2 patient groups

Dulaglutide 1.5 milligram (mg)

Experimental group

Description:

Participants received 1.5 mg of dulaglutide given weekly subcutaneously (SC) during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medication (OAM). Participants on dipeptidyl peptidase-4 inhibitors (DPP-4i) discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Treatment:

Drug: Dulaglutide

Drug: Oral antihyperglycemics

Dulaglutide 0.75 mg

Active Comparator group

Description:

Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Treatment:

Drug: Dulaglutide

Drug: Oral antihyperglycemics