Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2 Canagliflozin Hemoglobin A1c Metformin Sitagliptin T2DM JNJ-28431754
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 218
Healthy volunteers: no

Brief 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.

Detailed description:
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).

Arms:
arm 1: 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. arm 2: Each participant will receive placebo (inactive medication) once daily for 28 weeks.

Interventions: intervention 1: Canagliflozin, 100 mg intervention 2: Canagliflozin, 300 mg intervention 3: Placebo
Intervention descriptions: intervention 1: One 100 mg capsule taken orally (by mouth) once daily. intervention 2: One 300 mg capsule taken orally (by mouth) once daily. intervention 3: One placebo capsule taken orally (by mouth) once daily.

Protocol document: