An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Part of paid clinical trials in Concord, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01064414
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Canagliflozin — DRUG
    One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
  • Placebo — DRUG
    One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information

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 have reduced kidney function.

Key Dates

Start date
Jun 30, 2010
Status verified
Aug 2013
Primary completion
Dec 31, 2011
Completion
Aug 31, 2012

Study Design

Enrollment
272 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.
  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin once daily for 52 weeks.
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo once daily for 52 weeks.

Primary Outcome Measure

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

Locations (26)

FacilityCityStateZIPSite coordinators
-ConcordCalifornia--
-Fountain ValleyCalifornia--
-San DiegoCalifornia--
-DenverColorado--
-Pembroke PinesFlorida--
-TampaFlorida--
-West Palm BeachFlorida--
-AugustaGeorgia--
-NampaIdaho--
-Baton RougeLouisiana--
-JacksonMississippi--
-PicayuneMississippi--
-ChesterfieldMissouri--
-Las VegasNevada--
-AlbuquerqueNew Mexico--
-DurhamNorth Carolina--
-Canal FultonOhio--
-CincinnatiOhio--
-ColumbusOhio--
-ZanesvilleOhio--
-Oklahoma CityOklahoma--
-MeridianPennsylvania--
-PittsburghPennsylvania--
-North CharlestonSouth Carolina--
-Salt Lake CityUtah--
-FairfaxVirginia--

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By condition
Type 2 diabetes
By specialty
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