A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

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.

Timeline

Start

2011-08

Primary completion

2012-11

Completion

2012-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Canagliflozin 100 mg; p <0.001; Least-Squares Mean Difference -0.51 (95% CI -0.644 to -0.367); ANCOVA NCT01381900 ↗

registry analysis (superiority or other test); Placebo vs Canagliflozin 300 mg; p <0.001; Least-Squares Mean Difference -0.59 (95% CI -0.731 to -0.453); ANCOVA NCT01381900 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	100 mg	Oral
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	300 mg	Oral
Background	Metformin	Small molecule	—	—
Background	Sulphonylurea	Unknown	—	—

Indications