At a glance
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week 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 Alone or in Combination With a Sulphonylurea
In Brief
A Phase 3 clinical trial evaluating Placebo, Canagliflozin 100mg, and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 678 participants across 25 sites in 3 countries.
Detailed Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.
Study Details
Timeline
Interventions
Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
The participant's stable dose of background therapy of metformin should be continued throughout the study.
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.