A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT03131687
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- tirzepatide — DRUGAdministered SC
- Dulaglutide — DRUGAdministered SC
- Placebo — DRUGAdministered SC
Study Details
The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.
Key Dates
- Start date
- May 24, 2017
- Status verified
- Apr 2019
- Primary completion
- Aug 1, 2018
- Completion
- Aug 1, 2018
Study Design
- Enrollment
- 318 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboTirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
- Experimental: 1 mg Tirzepatide1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
- Experimental: 5 mg Tirzepatide5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
- Experimental: 10 mg Tirzepatide10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
- Experimental: 15 mg Tirzepatide15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
- Active Comparator: 1.5 mg Dulaglutide1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
Primary Outcome Measure
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response [ Time Frame: Baseline, Week 26 ]
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