Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Intarcia Therapeutics
Study ID
NCT02638805
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ITCA 650 Osmotic Mini Pump 20/60 mcg/day — DRUG
    ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
  • ITCA 650 Osmotic Mini Pump 60 mcg/day — DRUG
    ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
  • Metformin — DRUG
    Stable dose for at least 3 months (at least 1000 mg/day)
  • Liraglutide — DRUG
    Stable dose for at least 3 months (at least 1.2 mg/day)

Study Details

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

Key Dates

Start date
Dec 31, 2015
Status verified
Nov 2018
Primary completion
Oct 31, 2017
Completion
Oct 31, 2017

Study Design

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

Arms

  • Experimental: Group 1
    ITCA 650 20/60 mcg/day
  • Experimental: Group 2
    ITCA 650 60 mcg/day

Primary Outcome Measure

Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting [ Time Frame: From Randomization to 34 weeks ]

Locations (36)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLCBirminghamAlabama35235-
Saint Vincent's Medical Center (BRANY)Gulf ShoresAlabama36542-
Arkansas Primary Care Clinic, PALittle RockArkansas72204-
University of Colorado HospitalAuroraColorado--
Denver VA Medical CenterDenverColorado80220-
Meridien ResearchBrooksvilleFlorida34601-
International Research Associates, LLCHialeahFlorida33012-
Care Partners Clinical Research, LLCJacksonvilleFlorida32218-
AMPM Research ClinicMiamiFlorida33145-
Epocrates Medical and Research CenterMiamiFlorida33175-
Sensible Healthcare, LLCOcoeeFlorida34761-
Solaris Clinical ResearchMeridianIdaho83646-
American Health Network of Indiana, LLCAvonIndiana46123-
American Health Network of Indiana, LLCFranklinIndiana46131-
American Health Network of Indiana, LLCGreenfieldIndiana46140-
Cotton-O'Neil Clinical Research CenterTopekaKansas66606-
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-
Center for Advanced Medical ResearchCity of Saint PetersMissouri63303-
Radiant ResearchSt LouisMissouri63141-
Accent Clinical TrialsLas VegasNevada89119-
Palm Research Center, Inc.Las VegasNevada89148-
Manhattan Medical ResearchNew YorkNew York10016-
Novel Research of New YorkThe BronxNew York10461-
Carteret Medical Group, LLCMorehead CityNorth Carolina28557-
Prestige Clinical ResearchFranklinOhio45005-
LION ResearchNormanOklahoma73072-
Lynn Institute of the OzNormanOklahoma73069-
University of Tennessee Health Sciences CenterMemphisTennessee38103-
Coastal Bend Clinical ResearchCorpus ChristiTexas78414-
Dallas Diabetes and Endocrine CenterDallasTexas75230-
Juno Research, LLCHoustonTexas77036-
Sante Clinical ResearchKerrvilleTexas78028-
Clinical Trials of Texas, Inc.San AntonioTexas78229-
Panacea Clinical Research, LLCSan AntonioTexas78228-
Victorium Clinical Research Ltd.San AntonioTexas78229-
Erickson Research and DevelopmentClintonUtah84015-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Alabama Clinical Therapeutics, LLC· Birmingham, ALSaint Vincent's Medical Center (BRANY)· Gulf Shores, ALArkansas Primary Care Clinic, PA· Little Rock, ARUniversity of Colorado Hospital· Aurora, CODenver VA Medical Center· Denver, COMeridien Research· Brooksville, FL

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