The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01106677
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.
  • Canagliflozin — DRUG
    One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.
  • Sitagliptin — DRUG
    One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.
  • Metformin immediate release — DRUG
    The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.

Study Details

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

Key Dates

Start date
May 31, 2010
Status verified
Jul 2013
Primary completion
Oct 31, 2011
Completion
May 31, 2012

Study Design

Enrollment
1,284 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin 100 mg
    Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
  • Active Comparator: Sitagliptin 100 mg
    Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
  • Other: Placebo/Sitagliptin
    Each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin will be given with protocol-specified doses of metformin immediate release.

Primary Outcome Measure

Change in HbA1c From Baseline to Week 26 [ Time Frame: Day 1 (Baseline) and Week 26 ]

Locations (45)

FacilityCityStateZIPSite coordinators
-Little RockArkansas--
-Fountain ValleyCalifornia--
-National CityCalifornia--
-NorthridgeCalifornia--
-Colorado SpringsColorado--
-DenverColorado--
-BradentonFlorida--
-BrooksvilleFlorida--
-DeFuniak SpringsFlorida--
-HialeahFlorida--
-NicevilleFlorida--
-TampaFlorida--
-AtlantaGeorgia--
-SavannahGeorgia--
-ChampaignIllinois--
-AvonIndiana--
-FishersIndiana--
-FranklinIndiana--
-West Des MoinesIowa--
-WichitaKansas--
-MunfordvilleKentucky--
-PortlandMaine--
-BenzoniaMichigan--
-InterlochenMichigan--
-TroyMichigan--
-PicayuneMississippi--
-FlorissantMissouri--
-St LouisMissouri--
-Las VegasNevada--
-MansfieldNew Jersey--
-New Hyde ParkNew York--
-AsheboroNorth Carolina--
-CharlotteNorth Carolina--
-KetteringOhio--
-Oregon CityOregon--
-AltoonaPennsylvania--
-TiptonPennsylvania--
-East ProvidenceRhode Island--
-GreerSouth Carolina--
-Mt. PleasantSouth Carolina--
-NashvilleTennessee--
-New BraunfelsTexas--
-San AntonioTexas--
-BountifulUtah--
-SpokaneWashington--

Find similar trials in Little Rock, AR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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