The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01137812
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Sitagliptin 100 mg — DRUG
    One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
  • Canagliflozin 300 mg — DRUG
    One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
  • Metformin — DRUG
    Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
  • Sulphonylurea — DRUG
    Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.

Study Details

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

Key Dates

Start date
Jul 31, 2010
Status verified
Jan 2015
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

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

Arms

  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
  • Active Comparator: Sitagliptin 100 mg
    Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

Primary Outcome Measure

Change in HbA1c From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ]

Locations (85)

FacilityCityStateZIPSite coordinators
-MobileAlabama--
-GoodyearArizona--
-MesaArizona--
-EscondidoCalifornia--
-FresnoCalifornia--
-GreenbraeCalifornia--
-La MesaCalifornia--
-Laguna HillsCalifornia--
-LancasterCalifornia--
-Long BeachCalifornia--
-Los AngelesCalifornia--
-NorwalkCalifornia--
-Pismo BeachCalifornia--
-RosevilleCalifornia--
-Spring ValleyCalifornia--
-Walnut CreekCalifornia--
-WatsonvilleCalifornia--
-DenverColorado--
-NorthglennColorado--
-MilfordConnecticut--
-BradentonFlorida--
-Cape CoralFlorida--
-ClearwaterFlorida--
-Delray BeachFlorida--
-MiamiFlorida--
-Pembroke PinesFlorida--
-TampaFlorida--
-AtlantaGeorgia--
-LewistonIdaho--
-ChicagoIllinois--
-O'FallonIllinois--
-SpringfieldIllinois--
-TopekaKansas--
-Bowling GreenKentucky--
-LexingtonKentucky--
-MadisonvilleKentucky--
-Baton RougeLouisiana--
-MandevilleLouisiana--
-MetairieLouisiana--
-SunsetLouisiana--
-BrocktonMassachusetts--
-Saint Clair ShoresMichigan--
-SouthfieldMichigan--
-Dakota DunesNebraska--
-Toms RiverNew Jersey--
-AlbuquerqueNew Mexico--
-West SenecaNew York--
-CalabashNorth Carolina--
-GreensboroNorth Carolina--
-Moerhead CityNorth Carolina--
-MorgantonNorth Carolina--
-CincinnatiOhio--
-GallipolisOhio--
-MarionOhio--
-MasonOhio--
-ToledoOhio--
-ZanesvilleOhio--
-BeaverPennsylvania--
-BensalemPennsylvania--
-NorristownPennsylvania--
-PerryopolisPennsylvania--
-PhiladelphiaPennsylvania--
-PittsburghPennsylvania--
-PottstownPennsylvania--
-GreenvilleSouth Carolina--
-SpartanburgSouth Carolina--
-Johnson CityTennessee--
-DallasTexas--
-Fort WorthTexas--
-HoustonTexas--
-KilleenTexas--
-RichardsonTexas--
-San AntonioTexas--
-SchertzTexas--
-Sugar LandTexas--
-BurkeVirginia--
-DanvilleVirginia--
-Falls ChurchVirginia--
-HamptonVirginia--
-HenricoVirginia--
-ManassasVirginia--
-NorfolkVirginia--
-RichmondVirginia--
-SelahWashington--
-TacomaWashington--

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By condition
Type 2 diabetes
By specialty
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