Initial Combination Therapy With Canagliflozin Plus Metformin Versus Each Component as Monotherapy for Drug-Naïve Type 2 Diabetes

Diabetes Care
J RosenstockRong Qiu

Abstract

This study assessed the efficacy/safety of canagliflozin (CANA), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, plus metformin extended-release (MET) initial therapy in drug-naïve type 2 diabetes. This 26-week, double-blind, phase 3 study randomized 1,186 patients to CANA 100 mg (CANA100)/MET, CANA 300 mg (CANA300)/MET, CANA100, CANA300, or MET. Primary end point was change in HbA(1c) at week 26 for combinations versus monotherapies. Secondary end points included noninferiority in HbA(1c) lowering with CANA monotherapy versus MET; changes in fasting plasma glucose, body weight, and blood pressure; and proportion of patients achieving HbA(1c) <7.0% (<53 mmol/mol). From mean baseline HbA(1c) of 8.8% (73 mmol/mol), CANA100/MET and CANA300/MET significantly lowered HbA(1c) versus MET (median dose, 2,000 mg/day) by -1.77%, -1.78%, and -1.30% (-19.3, -19.5, and -14.2 mmol/mol; differences of -0.46% and -0.48% [-5.0 and -5.2 mmol/mol]; P = 0.001) and versus CANA100 and CANA300 by -1.37% and -1.42% (-15.0 and -15.5 mmol/mol; differences of -0.40% and -0.36% [-4.4 and -3.9 mmol/mol]; P = 0.001). CANA100 and CANA300 monotherapy met noninferiority for HbA(1c) lowering and had significantly more weight loss versus MET (-2.8, -3.7, and...Continue Reading

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Citations

Jul 29, 2016·Expert Opinion on Drug Metabolism & Toxicology·Elizabeth Mary Lamos, Stephen N Davis
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