drugset / Trial / NCT01809327

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

NCT01809327

Phase 3 Completed 1186 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.

Timeline

Start
2013-06-04
Primary completion
2014-12-02
Completion
2014-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 100 mg Oral
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 300 mg Oral
Subject Metformin Small molecule 2000 mg Oral