The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01081834
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 (Main Study) or 26 weeks (High Glycemic Substudy)
  • Placebo — DRUG
    One matching placebo capsule orally once daily for 26 weeks (Main Study)
  • Sitagliptin — DRUG
    One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)

Study Details

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

Key Dates

Start date
Mar 31, 2010
Status verified
Jun 2013
Primary completion
Aug 31, 2011
Completion
Mar 31, 2012

Study Design

Enrollment
678 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 (Main Study) or 26 weeks only (High Glycemic Substudy).
  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
  • Experimental: Placebo/Sitagliptin
    In the Main Study, 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.

Primary Outcome Measure

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

Locations (24)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--
-ConcordCalifornia--
-GreenbraeCalifornia--
-Los AngelesCalifornia--
-Spring ValleyCalifornia--
-Colorado SpringsColorado--
-DenverColorado--
-NorthglennColorado--
-SpringfieldIllinois--
-EvansvilleIndiana--
-Baton RougeLouisiana--
-MetairieLouisiana--
-MeridianNew Jersey--
-AlbuquerqueNew Mexico--
-New YorkNew York--
-West SenecaNew York--
-MooresvilleNorth Carolina--
-PerryopolisPennsylvania--
-PittsburghPennsylvania--
-TaylorsSouth Carolina--
-DallasTexas--
-HoustonTexas--
-San AntonioTexas--
-NorfolkVirginia--

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By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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