What are the benefits of canagliflozin in the treatment of type 2 diabetes mellitus (DM)?

Updated: Oct 23, 2019
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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Answer

FDA approval of canagliflozin was based on global phase 3 clinical trials that included over 10,000 patients. [193, 194] In a trial evaluating canagliflozin monotherapy efficacy and safety in 584 adults with type 2 diabetes mellitus inadequately controlled with diet and exercise, treatment for 26 weeks with canagliflozin 100 or 300 mg daily resulted in a statistically significant improvement in HbA1C with both doses compared with placebo. [199]

Canagliflozin add-on combination therapy to metformin and/or sulfonylureas showed a reduction in fasting glucose and a greater proportion of patients achieving an HbA1C level less than 7%. [200] Add-on therapy to insulin and comparative data to thiazolidinediones and to dipeptidyl peptidase-IV inhibitors have also shown improved postprandial glucose levels and HbA1C levels. [200]

In October 2019, canagliflozin received FDA approval for the treatment of diabetic kidney disease (DKD) and, in patients with type 2 diabetes and DKD, reduction in the risk of hospitalization for heart failure. Approval stemmed from the outcome of the phase 3 CREDENCE study, which found that at median 2.62-year follow-up, the risk of renal failure and cardiovascular events was lower in patients with type 2 diabetes and kidney disease who were treated with canagliflozin than in patients on placebo. [201]


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