The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01106625
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Canagliflozin — DRUG
    One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
  • Placebo — DRUG
    One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
  • Metformin — DRUG
    The patient's stable dose of background metformin therapy should be continued throughout the study.
  • Sulphonylruea — DRUG
    The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.

Study Details

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo 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
May 31, 2010
Status verified
Jun 2013
Primary completion
Sep 30, 2011
Completion
Apr 30, 2012

Study Design

Enrollment
469 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 and sulphonylurea.
  • 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.
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Primary Outcome Measure

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

Locations (37)

FacilityCityStateZIPSite coordinators
-HuntsvilleAlabama--
-Little RockAlaska--
-PhoenixArizona--
-ChinoCalifornia--
-Fair OaksCalifornia--
-RosevilleCalifornia--
-Wes HillsCalifornia--
-WaterburyConnecticut--
-JacksonvilleFlorida--
-New Port RicheyFlorida--
-OcalaFlorida--
-St. PetersburgFlorida--
-West Palm BeachFlorida--
-AugustaGeorgia--
-RoswellGeorgia--
-ChicagoIllinois--
-LexingtonKentucky--
-New OrleansLouisiana--
-ReisterstownMaryland--
-Olive BranchMississippi--
-St LouisMissouri--
-WestfieldNew York--
-GreenvilleNorth Carolina--
-CincinnatiOhio--
-TulsaOklahoma--
-MedfordOregon--
-AltoonaPennsylvania--
-HarleysvillePennsylvania--
-LevittownPennsylvania--
-SellersvillePennsylvania--
-GreerSouth Carolina--
-BryanTexas--
-DallasTexas--
-DeSotoTexas--
-Salt Lake CityUtah--
-South BurlingtonVermont--
-WenatcheeWashington--

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By condition
Type 2 diabetes
By specialty
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