A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

Part of paid clinical trials in Montgomery, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02025907
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Placebo — DRUG
    One placebo capsule taken orally (by mouth) once daily.

Study Details

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Key Dates

Start date
Feb 28, 2014
Status verified
Oct 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
218 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin (JNJ-28431754)
    Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.
  • Placebo Comparator: Placebo
    Each participant will receive placebo (inactive medication) once daily for 28 weeks.

Primary Outcome Measure

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline and Week 26 ]

Locations (30)

FacilityCityStateZIPSite coordinators
-MontgomeryAlabama--
-PhoenixArizona--
-Little RockArkansas--
-NorthridgeCalifornia--
-NorwalkCalifornia--
-Rancho CucamongaCalifornia--
-San RamonCalifornia--
-AuroraColorado--
-DenverColorado--
-LittletonColorado--
-Cooper CityFlorida--
-MiamiFlorida--
-North Miami BeachFlorida--
-AtlantaGeorgia--
-PerryGeorgia--
-Shawnee MissionKansas--
-MarreroLouisiana--
-MetairieLouisiana--
-MetarieLouisiana--
-RockvilleMaryland--
-JacksonMississippi--
-PicayuneMississippi--
-St LouisMissouri--
-NashuaNew Hampshire--
-AlbuquerqueNew Mexico--
-AlbanyNew York--
-ArlingtonTexas--
-San AntonioTexas--
-SugarlandTexas--
-BountifulUtah--

Find similar trials in Montgomery, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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