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
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|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|
|Actual Primary Completion Date :||September 2015|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025907
Show 57 Study Locations
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|