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
|ClinicalTrials.gov Identifier: NCT02025907|
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : September 2, 2016
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Canagliflozin, 100 mg Drug: Canagliflozin, 300 mg Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy|
|Study Start Date :||February 2014|
|Primary Completion Date :||September 2015|
|Study Completion Date :||September 2015|
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.
Drug: Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily.Drug: Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily.
Placebo Comparator: Placebo
Each participant will receive placebo (inactive medication) once daily for 28 weeks.
One placebo capsule taken orally (by mouth) once daily.
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline and Week 26 ]
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Baseline and Week 26 ]
- Percent Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline and Week 26 ]
- Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26 [ Time Frame: Week 26 ]
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 [ Time Frame: Baseline and Week 26 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025907
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|