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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Canagliflozin; Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Must have a diagnosis of type 2 diabetes mellitus

• Must have a screening HbA1c of >=7.5% to <=10.5%

• Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening

Exclusion Criteria:

• History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria

• A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening

• eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women

• Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)

• Major surgery (ie, requiring general anesthesia) within 12 weeks before screening