Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise

Stenlöf K, Cefalu WT, Kim KA, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15(4):372-382.  

Canagliflozin monotherapy showed significant A1C and fasting plasma glucose (FPG) reductions compared with placebo among subjects with type 2 diabetes inadequately controlled with diet and exercise in the CANTATA-M trial.

Mean change in A1C from baseline to Week 26, the study's primary endpoint, was -0.77% among subjects who received canagliflozin 100 mg, -1.03% among subjects who received canagliflozin 300 mg, and 0.14% among subjects who received placebo. Comparisons for both dosages versus placebo were statistically significant (P<0.001).

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Slide19 - Cantata-M Significant A1C Reductions  

A greater proportion of canagliflozin-treated subjects achieved A1C <7.0% at 26 weeks: 44.5%, 62.4%, and 20.6% in the canagliflozin 100-mg, canagliflozin 300-mg groups and placebo groups, respectively; P<0.001 for both canagliflozin doses.

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Slide20 - Cantata-M Greater Proportion  

Reductions in FPG were significantly greater among canagliflozin-treated subjects, as well: -27.0 mg/dL (-1.5 mmol/L), -34.2 mg/dL (-1.9 mmol/L), and 9.01 mg/dL (0.5 mmol/L) in the canagliflozin 100-mg, canagliflozin 300-mg, and placebo groups, respectively; P<0.001 for both canagliflozin doses versus placebo at 26 Weeks.

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Slide21 - Cantata-M Significant FPG Reductions  

Statistically significant reductions in weight and systolic blood pressure were also seen with canagliflozin treatment. With regard to lipid values, significant increases in HDL-C were seen in both canagliflozin groups; nonsignificant reductions in triglycerides were also observed.

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Slide22 - Cantata-M Significant Weight Reductions  Slide23 - Cantata-M Significant Reductions  Slide24 - Cantata-M Effect of Canagliflozin  

The overall incidence of adverse events in CANTATA-M was modestly higher among canagliflozin-treated patients versus placebo; there were no reports of severe hypoglycemia. Genital mycotic infections, osmotic diuresis (polyuria), and urinary tract infections were increased with canagliflozin treatment.

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Slide25 - Cantata-M Adverse Events
 

CANTATA-M was a 26-week, randomized, double-blind, placebo-controlled Phase III study. Subjects had A1C  ≥7.0% to ≤10% and were randomized 1:1:1 to once-daily canagliflozin 100 mg (n=195), canagliflozin 300 mg (n=197), or placebo (n=192). Mean baseline A1C in the trial was 8.0%, FPG, 171.2 mg/dL, mean type 2 diabetes duration, 4.3 years.

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Slide18 - Cantata-M Design  

Canagliflozin is not indicated for weight loss or antihypertensive or lipid-lowering treatment. One formulation of canagliflozin (INVOKANA™) has been FDA approved as of May 2013.

CANTATA-M=Canagliflozin Treatment and Trial Analysis–Monotherapy

 

Related content: 

Slide: SGLT2 Inhibitors for Treatment of Type 2 Diabetes 

Overview: Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea 

 

The pharmacologic agents discussed are approved for use in the United States by the U.S. Food and Drug Administration (FDA) unless otherwise noted. Consult individual prescribing information for approved uses outside of the United States. 

May 2013 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest.  

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Last Modified: 3/23/2015