At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 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 Sulphonylurea Therapy
In Brief
A Phase 3 clinical trial evaluating Canagliflozin, Placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 469 participants across 76 sites in 12 countries.
Detailed 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 and sulphonylurea and have inadequate glycemic (blood sugar) control.
Study Details
Timeline
Interventions
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
The patient's stable dose of background metformin therapy should be continued throughout the study.
The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.