A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01989754
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    One placebo capsule taken orally (by mouth) once daily for 156 weeks
  • Canagliflozin, 100 mg — DRUG
    One 100 mg capsule taken orally (by mouth) once daily
  • Canagliflozin, 300 mg — DRUG
    One 300 mg capsule taken orally (by mouth) once daily

Study Details

The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

Key Dates

Start date
Jan 16, 2014
Status verified
Nov 2018
Primary completion
Feb 23, 2017
Completion
Feb 23, 2017

Study Design

Enrollment
5,813 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin (JNJ-28431754)
    Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 13 weeks, then the dose may be increased to 300 mg once daily.
  • Placebo Comparator: Placebo
    Each patient will receive placebo (inactive medication) once daily.

Primary Outcome Measure

Progression of Albuminuria [ Time Frame: Up to 3 years ]

Locations (57)

FacilityCityStateZIPSite coordinators
-Little RockArkansas--
-CarmichaelCalifornia--
-ConcordCalifornia--
-Pismo BeachCalifornia--
-RosevilleCalifornia--
-Thousand OaksCalifornia--
-DenverColorado--
-HollywoodFlorida--
-JacksonvilleFlorida--
-MiamiFlorida--
-New Port RicheyFlorida--
-Opa-lockaFlorida--
-OrlandoFlorida--
-Palm HarborFlorida--
-TampaFlorida--
-MeridianIdaho--
-ChicagoIllinois--
-ValparaisoIndiana--
-TopekaKansas--
-LouisvilleKentucky--
-MandevilleLouisiana--
-MetairieLouisiana--
-ElkridgeMaryland--
-FlintMichigan--
-PicayuneMississippi--
-Kansas CityMissouri--
-St LouisMissouri--
-WashingtonMissouri--
-OmahaNebraska--
-Las VegasNevada--
-CorneliusNorth Carolina--
-HickoryNorth Carolina--
-MooresvilleNorth Carolina--
-Canal FultonOhio--
-FranklinOhio--
-MasonOhio--
-Oklahoma CityOklahoma--
-BeaverPennsylvania--
-LevittownPennsylvania--
-NorristownPennsylvania--
-PittsburghPennsylvania--
-TiptonPennsylvania--
-GreerSouth Carolina--
-Jefferson CityTennessee--
-AustinTexas--
-PearlandTexas--
-BountifulUtah--
-DraperUtah--
-Salt Lake CityUtah--
-West JordanUtah--
-South BurlingtonVermont--
-Falls ChurchVirginia--
-NorfolkVirginia--
-Virginia BeachVirginia--
-SpokaneWashington--
-MilwaukeeWisconsin--
-WauwatosaWisconsin--

Find similar trials in Little Rock, AR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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