An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

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.

Timeline

Start

2011-07

Primary completion

2012-04

Completion

2012-04

Outcome

Met primary endpoint

registry Placebo vs Canagliflozin 50 mg Bid; p <0.001; Least-Squares Mean Difference -0.44 (95% CI -0.637 to -0.251); ANCOVA NCT01340664 ↗

registry Placebo vs Canagliflozin 150 mg Bid; p <0.001; Least-Squares Mean Difference -0.60 (95% CI -0.792 to -0.407); ANCOVA NCT01340664 ↗

Publications

• Qiu R, Capuano G, Meininger G. Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus. J Clin Transl Endocrinol. 2014 May 5;1(2):54-60. doi: 10.1016/j.jcte.2014.04.001. eCollection 2014 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	50 mg	Oral
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	150 mg	Oral
Background	Metformin	Small molecule	—	—

Indications