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

Sponsor
Eli Lilly and Company
Study ID
NCT04809220
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide — DRUG
    Administered SC
  • Oral antihyperglycemics — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Apr 13, 2021
Status verified
Apr 2024
Primary completion
Oct 1, 2022
Completion
Apr 26, 2023

Study Design

Enrollment
591 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dulaglutide 1.5 milligram (mg)
    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.
  • Active Comparator: Dulaglutide 0.75 mg
    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.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Baseline, Week 26 ]

Related Studies