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

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

Outcome

Met primary endpoint

paper CANA100/MET and CANA300/MET significantly lowered HbA(1c) versus MET (median dose, 2,000 mg/day) PMID 26786577 ↗

paper differences of -0.46% and -0.48% [-5.0 and -5.2 mmol/mol]; P = 0.001 PMID 26786577 ↗

Publications

Rosenstock J, Chuck L, Gonzalez-Ortiz M, Merton K, Craig J, Capuano G, Qiu R. Initial Combination Therapy With Canagliflozin Plus Metformin Versus Each Component as Monotherapy for Drug-Naive Type 2 Diabetes. Diabetes Care. 2016 Mar;39(3):353-62. doi: 10.2337/dc15-1736. Epub 2016 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	100 mg	Oral
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	300 mg	Oral
Subject	Metformin	Small molecule	2000 mg	Oral