A Study of Dulaglutide in Chinese Participants

Sponsor
Eli Lilly and Company
Study ID
NCT01667900
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Dulaglutide — DRUG
  • Placebo — DRUG
    Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.

Study Details

This is a study of dulaglutide in Chinese participants. The purpose of the study is to determine how the body processes dulaglutide and how dulaglutide affects the body. This study has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of 3 study periods. There is a minimum 28-day washout between periods. Part A will last approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks. Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this study.

Key Dates

Start date
Aug 31, 2012
Status verified
Feb 2016
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

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

Arms

  • Experimental: 0.5 mg Dulaglutide (Part A-Healthy)
    0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods
  • Experimental: 0.75 mg Dulaglutide (Part A-Healthy)
    0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
  • Experimental: 1.5 mg Dulaglutide (Part A-Healthy)
    1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
  • Placebo Comparator: Placebo (Part A-Healthy)
    Placebo administered once SQ to healthy participants in 1 of 3 treatment periods
  • Experimental: 0.5 mg Dulaglutide (Part B-T2DM)
    0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks
  • Experimental: 0.75 mg Dulaglutide (Part B-T2DM)
    0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
  • Experimental: 1.5 mg Dulaglutide (Part B-T2DM)
    1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
  • Placebo Comparator: Placebo (Part B-T2DM)
    Placebo administered to participants with T2DM once weekly SQ for 4 weeks

Primary Outcome Measure

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide [ Time Frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose ]

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