A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Part of paid clinical trials in Fresno, California.

Sponsor
Eli Lilly and Company
Study ID
NCT03311724
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.

Key Dates

Start date
Oct 19, 2017
Status verified
Apr 2021
Primary completion
Apr 24, 2018
Completion
Apr 24, 2018

Study Design

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

Arms

  • Experimental: 4,8,12mg Tirzepatide
    Participants received Tirzepatide by subcutaneous (SC) injection in three dose escalations starting with 4 milligrams (mg) for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
  • Experimental: 2.5,5,10,15mg Tirzepatide
    Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
  • Experimental: 2.5,7.5,15mg Tirzepatide
    Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
  • Placebo Comparator: Placebo
    Placebo administered by SC injection.

Primary Outcome Measure

Change From Baseline in Haemoglobin A1c (HbA1c) [ Time Frame: Baseline, 3 Months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Valley ResearchFresnoCalifornia93720-
National Research InstituteLos AngelesCalifornia90057-
Catalina Research Institute, LLCMontclairCalifornia91763-
University Clinical Investigators, Inc.TustinCalifornia92780-
Chase Medical Research, LLCWaterburyConnecticut06708-
Suncoast Research Group, LLCMiamiFlorida33135-
Solaris Clinical ResearchMeridianIdaho83646-
Cotton O'Neil Diabetes and Endocrinology CenterTopekaKansas66606-
Clinical Research ProfessionalsSt LouisMissouri63141-
Aventiv ResearchColumbusOhio43213-
New Phase Research & DevelopmentKnoxvilleTennessee37909-
Dallas Diabetes Endocrine CenterDallasTexas75230-
Consano Clinical ResearchShavano ParkTexas78231-

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