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

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: Placebo
    Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
  • Experimental: 1 mg Tirzepatide
    1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
  • Experimental: 5 mg Tirzepatide
    5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
  • Experimental: 10 mg Tirzepatide
    10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
  • Experimental: 15 mg Tirzepatide
    15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
  • Active Comparator: 1.5 mg Dulaglutide
    1.5 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 ]

Locations (35)

FacilityCityStateZIPSite coordinators
Internal Medicine Center LLCMobileAlabama36608-
Anaheim Clinical TrailsAnaheimCalifornia92801-
Valley ResearchFresnoCalifornia93720-
National Research InstituteHuntington ParkCalifornia90255-
National Research InstituteLos AngelesCalifornia90057-
Catalina Research InstituteMontclairCalifornia91763-
Valley Clinical Trails, IncNorthridgeCalifornia91325-
Artemis Institute For Clinical ResearchSan DiegoCalifornia92103-
Artemis Institute For Clinical ResearchSan MarcosCalifornia92078-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
University Clinical Investigators INCTustinCalifornia92780-
Chase Medical ResearchWaterburyConnecticut06708-
Clinical Research of South FloridaCoral GablesFlorida33134-
East Coast Institute For ResearchJacksonvilleFlorida32216-
New Horizon Research CenterMiamiFlorida33175-
Suncoast Research Group, LCCMiamiFlorida33135-
Sensible HealthcareOcoeeFlorida34761-
Palm Harbor Medical AssociatePalm HarborFlorida34684-
Solaris Clinical ResearchMeridianIdaho83646-
Iderc P.L.C.West Des MoinesIowa50265-
Cotton O'Neil Diabetes and EndocrineTopekaKansas66606-
ActivMed Practices & ResearchMethuenMassachusetts01844-
Clinical Research ProfessionalsSt LouisMissouri63141-
Palm Research CenterLas VegasNevada89128-
Premier ResearchTrentonNew Jersey08611-
Manhattan Medical ResearchNew YorkNew York10016-
Lillestol Research LLCFargoNorth Dakota58103-
Aventiv ResearchColumbusOhio43213-
The Corvallis Clinic P.C.CorvallisOregon97330-
PMG Research Of Charleston LLCMoncks CornerSouth Carolina29461-
New Phase Research & DevelopmentKnoxvilleTennessee37909-
PMG Research Of KnoxvilleKnoxvilleTennessee37938-
Dallas Diabetes Endocrine CenterDallasTexas75230-
Consano Clinical ResearchShavano ParkTexas78231-
Chrysalis Clinical ResearchSt. GeorgeUtah84790-

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