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
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.
Diabetes Mellitus, Type 2
Drug: Canagliflozin, 100 mg
Drug: Canagliflozin, 300 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: Day 1 (baseline), up to Week 26 ] [ Designated as safety issue: No ]
- Evaluation of safety and tolerability of canagliflozin by monitoring the Adverse Events [ Time Frame: Baseline, up to the end of post -treatment period, approximately 28 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline, up to Week 26 ] [ Designated as safety issue: No ]
- Change from baseline in percentage of body weight [ Time Frame: Baseline, up to Week 26 ] [ Designated as safety issue: No ]
- Proportions of patients with HbA1c <7.0% [ Time Frame: Baseline, up to Week 26 ] [ Designated as safety issue: No ]
- Change from baseline in systolic blood pressure (SBP) [ Time Frame: Baseline, up to Week 26 ] [ Designated as safety issue: No ]
- Change from baseline in diastolic blood pressure (DBP) [ Time Frame: Baseline, up to Week 26 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02025907
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
Show 84 Study Locations
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|