A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

Part of paid clinical trials in Sheffield, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT04537923
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Insulin Lispro (U100) — DRUG
    Administered SC

Study Details

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

Key Dates

Start date
Oct 19, 2020
Status verified
Oct 2023
Primary completion
Oct 11, 2022
Completion
Nov 1, 2022

Study Design

Enrollment
1,428 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5 mg Tirzepatide
    5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
  • Experimental: 10 mg Tirzepatide
    10 mg tirzepatide administered SC once a week.
  • Experimental: 15 mg Tirzepatide
    15 mg tirzepatide administered SC once a week.
  • Active Comparator: Insulin Lispro
    Insulin lispro 100 units per milliliter (U100) administered SC three times a day.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 52 ]

Locations (40)

FacilityCityStateZIPSite coordinators
Syed Research Consultants LlcSheffieldAlabama35660-
Valley ResearchFresnoCalifornia93720-
National Research Institute - Huntington ParkHuntington ParkCalifornia90255-
National Research Institute - Huntington ParkLos AngelesCalifornia90057-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
National Research Institute - Huntington ParkPanorama CityCalifornia91402-
National Research Institute (NRI) - Santa AnaSanta AnaCalifornia92704-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
University Clinical Investigators, Inc.TustinCalifornia92780-
University of ColoradoAuroraColorado80045-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
I R & Health Center, Inc.HialeahFlorida33012-
Sun Coast Clinical Research, IncNew Port RicheyFlorida34652-
South Broward ResearchPembroke PinesFlorida33027-
Metabolic Research Institute, Inc.West Palm BeachFlorida33401-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
J H. Stroger Hosp of Cook CoChicagoIllinois60612-
Prairie Education and Research CooperativeSpringfieldIllinois62711-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
Capital Diabetes and Endocrine AssociatesCamp SpringsMaryland20746-
MedStar Health Research InstituteHyattsvilleMaryland20782-
Endocrine and Metabolic ConsultantsRockvilleMaryland20852-
Glacier View Research Institute - EndocrinologyKalispellMontana59901-
Southern Nh Diabetes and EndocrinologyNashuaNew Hampshire03060-
Albany Medical CollegeAlbanyNew York12203-
PMG Research of WilmingtonWilmingtonNorth Carolina28401-
Intend Research, LLCNormanOklahoma73069-
Heritage Valley Medical Group, Inc.BeaverPennsylvania15009-
Preferred Primary Care PhysiciansUniontownPennsylvania15401-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Dallas Diabetes Research CenterDallasTexas75230-
Diabetes and Thyroid Center of Fort WorthFort WorthTexas76132-
Biopharma Informatic, LLCHoustonTexas77084-
Juno ResearchHoustonTexas77040-
North Hills Medical ResearchNorth Richland HillsTexas76180-
Texas Diabetes & Endocrinology, P.A.Round RockTexas78681-
Clinical Trials of Texas, Inc.San AntonioTexas78229-
Consano Clinical Research, LLCShavano ParkTexas78231-
Martin Diagnostic ClinicTomballTexas77375-
Rainier Clinical Research CenterRentonWashington98057-

Find similar trials in Sheffield, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Syed Research Consultants Llc· Sheffield, ALValley Research· Fresno, CANational Research Institute - Huntington Park· Huntington Park, CANational Research Institute - Huntington Park· Los Angeles, CAValley Clinical Trials, Inc.· Northridge, CANational Research Institute - Huntington Park· Panorama City, CA

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