Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

Part of paid clinical trials in Fountain Hills, Arizona.

Sponsor
Intarcia Therapeutics
Study ID
NCT03060980
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ITCA 650 20/60 mcg/day — DRUG
    ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
  • Empagliflozin (oral) — DRUG
    10 mg/day and 25 mg/day
  • Glimepiride (oral) — DRUG
    1-6 mg/day

Study Details

A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.

Key Dates

Start date
Mar 3, 2017
Status verified
Mar 2019
Primary completion
Jan 26, 2018
Completion
Jan 26, 2018

Study Design

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

Arms

  • Experimental: Experimental: Group 1
    ITCA 650 20/60 mcg/day
  • Experimental: Experimental: Group 2
    Empagliflozin 10 mg/day and 25 mg/day
  • Experimental: Experimental: Group 3
    Glimepiride 1-6 mg/day

Primary Outcome Measure

Reduction in glycosylated hemoglobin A1c [ Time Frame: Randomization to 69 weeks ]

Locations (96)

FacilityCityStateZIPSite coordinators
Fountain Hills Family Practice, P.C.Fountain HillsArizona85268-
Thomas C. Lenzmeier, M.D., P.C.GlendaleArizona85308-
Central Phoenix Medical CenterPhoenixArizona85020-
Family Practice SpecialistsPhoenixArizona85018-
Fiel Family and Sports MedicineTempeArizona85283-
Arizona Community PhysiciansTucsonArizona85712-
Orange Grove Family PracticeTucsonArizona85741-
Anaheim Clinical TrialsAnaheimCalifornia92801-
Radiant ResearchCarlsbadCalifornia92008-
Research Center of Fresno, Inc.FresnoCalifornia93726-
Marin Endocrine Care and Research, Inc.GreenbraeCalifornia94904-
National Research InstituteHuntington ParkCalifornia90255-
National Research InstituteLos AngelesCalifornia91402-
Catalina Research InstituteMontclairCalifornia91710-
Providence Clinical ResearchNorth HollywoodCalifornia91606-
Center for Clinical Trials of Sacramento, Inc.SacramentoCalifornia95816-
Denver VA Medical CenterAuroraColorado80045-
Radiant ResearchCentennialColorado75115-
Colorado Springs Health Partners - EastColorado SpringsColorado80922-
Columbine Family PracticeLittletonColorado80128-
Nature Coast Clinical Reseaerch - Crystal RiverCrystal RiverFlorida34429-
Indago Research and Health Center, Inc.HialeahFlorida33012-
Clinical Neuroscience Solutions, Inc.JacksonvilleFlorida32256-
Research Institure of South FloridaMiamiFlorida33173-
Clinical Neuroscience Solutions, Inc.OrlandoFlorida32801-
Palm Harbor Medical AssociatesPalm HarborFlorida34684-
Andres Patron, D.O., P.APembroke PinesFlorida33026-
South Broward ResearchPembroke PinesFlorida33027-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Primary Care Research GroupAtlantaGeorgia30312-
Solaris Clinical ResearchMeridianIdaho83646-
Michigan Avenue InternistsChicagoIllinois60604-
Medical and Procedural SpecialistsSkokieIllinois60077-
HSHS Medical Group DIabetes ResearchSpringfieldIllinois62711-
Community Hospital of Anderson and Madison County, Inc.AndersonIndiana46011-
Clinical Research AdvantageEvansvilleIndiana47225-
American Health Network of Indiana, LLCFranklinIndiana46131-
American Health Network of Indiana, LLCNew AlbanyIndiana47150-
Heartland Research Associates, LLCAugustaKansas67010-
Overland Park Surgical Specialists, LLL dba College Park Family Care CenterOverland ParkKansas66210-
Cotton O'Neil Clinical Research CenterTopekaKansas66606-
Heartland Research Associates, LLCWichitaKansas67205-
Heartland Research Associates, LLCWichitaKansas67207-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-
Maine Research AssociatesAuburnMaine04210-
Joslin Diabetes CenterBostonMassachusetts02215-
Radiant Research, Inc.EdinaMinnesota55435-
Ehrhardt Clinical Research, LLCBeltonMissouri64012-
HealthCare Research NetworkHazelwoodMissouri63042-
Mercury Street Medical GroupButteMontana59701-
Skyline Medical CenterElkhornNebraska68022-
Nevada Family CareHendersonNevada89047-
Palm Research Center, Inc.Las VegasNevada89148-
Albany Medical CollegeAlbanyNew York12208-
Scott Research CenterLaureltonNew York11413-
American Health ResearchCharlotteNorth Carolina28207-
Medication Management, LLCGreensboroNorth Carolina27408-
Down East Medical Associates, PAMorehead CityNorth Carolina28557-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28401-
Radiant ResearchAkronOhio44311-
Sentral Clinical Research Services, LLCCincinnatiOhio45236-
Aventiv ResearchColumbusOhio43231-
Canyon Medical Center, LLCColumbusOhio43213-
Prestige Clinical ResearchFranklinOhio45005-
Wells Institute for Health AwarenessKetteringOhio45429-
University of ToledoToledoOhio43614-
Oklahoma City Clinic - Midwest CityMidwest CityOklahoma73110-
Intend ResearchNormanOklahoma73069-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Oklahoma City Clinic - CentralOklahoma CityOklahoma73104-
Clinical Research Institute of Southern Oregon, PCMedfordOregon97504-
Harleysville Medical AssociatesHarleysvillePennsylvania19438-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Preferred Primary Care Phys IncPittsburghPennsylvania15243-
Preferred Primary Care PhysiciansUniontownPennsylvania15401-
Clinical Research of Rock HillRock HillSouth Carolina29732-
Spartanburg Medical ResearchSpartanburgSouth Carolina29303-
Holston Medical Group, P.C.KingsportTennessee37660-
Clinical Neuroscience Solutions, Inc.MemphisTennessee38119-
DCT-AACT, LLC dba Discovery Clinical TrialsAustinTexas78758-
Dallas Diabetes and Endocrine CenterDallasTexas75230-
Research Institute of DallasDallasTexas75231-
Global Medical ResearchDeSotoTexas75115-
Juno ResearchHoustonTexas77004-
PCP for Life - -TidwellHoustonTexas77093-
Sante Clinical ResearchKerrvilleTexas78028-
Health Texas Research InstituteSan AngeloTexas78228-
Clinical Trials of Texas, Inc.San AntonioTexas78229-
MacGregor Medical CenterSan AntonioTexas78240-
Panacea Clinical ResearchSan AntonioTexas78228-
Victorium Clinical Research Ltd.San AntonioTexas78230-
Crossroads Clinical Research, LLCVictoriaTexas77901-
Ericksen Research and Development, LLCClintonUtah84015-
Radiant ResearchMurrayUtah84123-
Advanced Clinical ResearchWest JordanUtah84088-
Sound HealthcarePort OrchardWashington98366-

Find similar trials in Fountain Hills, AZ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Fountain Hills Family Practice, P.C.· Fountain Hills, AZThomas C. Lenzmeier, M.D., P.C.· Glendale, AZCentral Phoenix Medical Center· Phoenix, AZFamily Practice Specialists· Phoenix, AZFiel Family and Sports Medicine· Tempe, AZArizona Community Physicians· Tucson, AZ

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