A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company
Study ID
NCT02750410
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dulaglutide — DRUG
    Administered subcutaneously (SC)
  • Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.

Key Dates

Start date
Aug 31, 2016
Status verified
Sep 2019
Primary completion
Jun 18, 2018
Completion
Jun 18, 2018

Study Design

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

Arms

  • Experimental: Dulaglutide
    Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks.
  • Placebo Comparator: Placebo
    Placebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 16 ]

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