A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT03730662
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Administered SC.
  • Insulin Glargine — DRUG
    Administered SC

Study Details

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

Key Dates

Start date
Nov 20, 2018
Status verified
Jan 2022
Primary completion
Jan 22, 2021
Completion
Apr 22, 2021

Study Design

Enrollment
2,002 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 Glargine
    Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.

Primary Outcome Measure

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

Locations (74)

FacilityCityStateZIPSite coordinators
Advanced Research CenterAnaheimCalifornia92805-
Valley Clinical Trials, Inc.CovinaCalifornia91723-
Marin Endocrine AssociatesGreenbraeCalifornia94904-
National Research InstituteHuntington ParkCalifornia90255-
Scripps Whittier Diabetes InstituteLa JollaCalifornia92037-
First Valley Medical GroupLancasterCalifornia93534-
National Research InstituteLos AngelesCalifornia90057-
Catalina Research Institute, LLCMontclairCalifornia91763-
Monterey Endocrine & Diabetes Institute, Inc.MontereyCalifornia93940-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
Desert Medical Group IncPalm SpringsCalifornia92262-
Havana Research InstitutePasadenaCalifornia91105-
Western University of Health SciencesPomonaCalifornia91766-
LCGK ResearchSan CarlosCalifornia94070-
Olive View Medical CenterSylmarCalifornia91342-
University Clinical Investigators, Inc.TustinCalifornia92780-
Touro UniversityVallejoCalifornia94592-
Coastal Metabolic Research CentreVenturaCalifornia93003-
Diablo Clinical ResearchWalnut CreekCalifornia94598-
Chase Medical Research, LLCWaterburyConnecticut06708-
ALL Medical Research, LLCCooper CityFlorida33024-
Advanced Pharma ResearchCutler BayFlorida33189-
South Florida Wellness & Clinical Research InstituteMargateFlorida33063-
New Horizon Research CenterMiamiFlorida33165-
Suncoast Research Group, LLCMiamiFlorida33135-
Clinical Neuroscience Solutions IncOrlandoFlorida32801-
Progressive Medical ResearchPort OrangeFlorida32127-
Primary Care Specialists, LLCAtlantaGeorgia30312-
Rocky Mountain Diabetes and Osteoporosis CenterIdaho FallsIdaho83404-
Solaris Clinical ResearchMeridianIdaho83646-
Saltzer Medical Group. P.A.NampaIdaho83686-
Northwestern Feinberg School of MedicineChicagoIllinois60611-
NorthShore University HealthSystemSkokieIllinois60077-
University of Iowa Hospital & ClinicIowa CityIowa52242-
Iowa Diabetes ResearchWest Des MoinesIowa50265-
Cotton O'Neil Diabetes and Endocrinology CenterTopekaKansas66606-
Robley Rex VAMCLouisvilleKentucky40206-
NECCR PrimaCare Research, LLCFall RiverMassachusetts02721-
AA Medical Research CenterFlintMichigan48504-
Troy Internal Medicine, PCTroyMichigan48098-
Clinical Research ProfessionalsChesterfieldMissouri63005-
Glacier View Research InstituteKalispellMontana59901-
Montana Medical Research, IncMissoulaMontana59808-
Palm Research CenterLas VegasNevada89128-
Palm Research CenterLas VegasNevada89148-
Southern New Hampshire Diabetes and EndocrinologyNashuaNew Hampshire03063-
PharmQuestGreensboroNorth Carolina27408-
Lillestol Research LLCFargoNorth Dakota58104-
Rapid Medical Research IncClevelandOhio44122-
Aventiv ResearchColumbusOhio43213-
Ohio State Univ College Of MedicineColumbusOhio43210-
Intend ResearchNormanOklahoma73069-
The Corvallis Clinic P.C.CorvallisOregon97330-
Oregon Health and Science UniversityPortlandOregon97239-
Heritage Valley Medical Group, Inc.BeaverPennsylvania15009-
Capital Area ResearchCamp HillPennsylvania17011-
Detweiler Family MedicineLansdalePennsylvania19446-
Capital Area ResearchNewportPennsylvania17074-
Parkside Family MedicalPhiladelphiaPennsylvania19144-
Preferred Primary Care Physicians- Bower HillPittsburghPennsylvania15243-
Mountain View Clinical Research, Inc.GreerSouth Carolina29651-
The Research Center of the UpstateMauldinSouth Carolina29662-
Holston Medical Group Clinical ResearchKingsportTennessee37660-
New Phase Research & DevelopmentKnoxvilleTennessee37909-
Dallas Diabetes Endocrine CenterDallasTexas75230-
PCP for LifeHoustonTexas77070-
BFHC ResearchSan AntonioTexas78249-
Consano Clinical ResearchShavano ParkTexas78231-
Martin Diagnostic ClinicTomballTexas77375-
Alpine Research OrganizationFarmingtonUtah84025-
Burke Internal Medicine & ResearchBurkeVirginia22015-
Private: Dr. Larry StonesiferFederal WayWashington98003-
Capital Clinical Research CenterOlympiaWashington98502-
Walla Walla ClinicWalla WallaWashington99362-

Find similar trials in Anaheim, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Advanced Research Center· Anaheim, CAValley Clinical Trials, Inc.· Covina, CAMarin Endocrine Associates· Greenbrae, CANational Research Institute· Huntington Park, CAScripps Whittier Diabetes Institute· La Jolla, CAFirst Valley Medical Group· Lancaster, CA

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