Conditions: Diabetes Mellitus, Type 2
Keywords: Canagliflozin Placebo Metformin Hemoglobin A1c Type 2 diabetes mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 279
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Detailed description:
This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study.

Arms:
arm 1: Each patient will receive 50 mg canagliflozin twice daily for 18 weeks. arm 2: Each patient will receive 150 mg canagliflozin twice daily for 18 weeks arm 3: Each patient will receive matching placebo twice daily for 18 weeks

Interventions: intervention 1: Canagliflozin 50 mg intervention 2: Placebo intervention 3: Canagliflozin 150 mg intervention 4: Metformin
Intervention descriptions: intervention 1: One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks intervention 2: 1 placebo capsule taken orally twice daily with a meal for 18 weeks intervention 3: 1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks intervention 4: The patient's stable daily dose of Metformin background therapy should be continued throughout the study.

Protocol document: