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Add-on therapy

Canagliflozin + metformin demonstrated significantly greater reductions in A1C vs placebo + metformin at 26 weeks1

Adjusted Mean Change in A1C From Baseline at 26 Weeks (%)


Reductions in A1C: canagliflozin + metformin vs placebo + metformin Reductions in A1C: canagliflozin + metformin vs placebo + metformin
  • Canagliflozin 100 mg difference from placebo: –0.62% (95% CI: –0.76, –0.48; P <0.001)
  • Canagliflozin 300 mg difference from placebo: –0.77% (95% CI: –0.91, –0.64; P <0.001)

 

The primary endpoint was the change in A1C vs placebo from baseline through week 26; change in A1C vs sitagliptin was a prespecified secondary endpoint at week 52.1

Secondary endpoint: Percent of patients who achieved the A1C goal of <7.0% vs placebo at 26 weeks1,2

  • 46% with canagliflozin 100 mg + metformin*
  • 58% with canagliflozin 300 mg + metformin*
  • 30% with placebo + metformin

*P <0.001 vs placebo.

Canagliflozin 300 mg + metformin demonstrated superior reductions vs sitagliptin 100 mg + metformin across multiple secondary endpoints at 52 weeks1


Canagliflozin 300 mg + metformin demonstrated greater reductions vs sitagliptin 100 mg + metformin across multiple secondary endpoints at 52 weeks

Assuming a group difference of 0.5% (5.5 mmol/mol) between canagliflozin and placebo and a common SD of 1.0% (10.9 mmol/mol) for change in A1C, and using a 2-sample, 2-sided t test with a type 1 error rate of 0.05, an estimated 86 participants per group were required to achieve 90% power to demonstrate statistical superiority of canagliflozin to placebo.

    Secondary endpoint: Canagliflozin 100 mg and 300 mg + metformin demonstrated similar and superior reductions in A1C, respectively, vs sitagliptin 100 mg + metformin at 52 weeks

    Adjusted Mean Change in A1C From Baseline at 52 Weeks (%)


    Reductions in A1C: canagliflozin 100 mg plus metformin and canagliflozin 300 mg plus metformin vs sitagliptin 100 mg plus metformin Reductions in A1C: canagliflozin 100 mg plus metformin and canagliflozin 300 mg plus metformin vs sitagliptin 100 mg plus metformin
    • Canagliflozin 100 mg difference from sitagliptin: 0.00% (95% CI: –0.12, 0.12)
    • Canagliflozin 300 mg difference from sitagliptin: –0.15% (95% CI: –0.27, –0.03)

     

    Secondary endpoint: Percent of patients who achieved the A1C goal of <7.0% vs sitagliptin 100 mg at 52 weeks1,2

    • 41.4% with canagliflozin 100 mg + metformin
    • 54.7% with canagliflozin 300 mg + metformin
    • 50.6% with sitagliptin + metformin
       

    SELECT IMPORTANT SAFETY INFORMATION FROM PRESCRIBING INFORMATION

    • Individualize the starting dose of INVOKAMET® XR, taken once daily with the morning meal, based on the effectiveness and tolerability of the patient's current regimen3
    • Limit the dose of INVOKAMET® XR to 2 tablets, each tablet containing canagliflozin 50 mg, in patients with moderate renal impairment with an eGFR of 45 to <60 mL/min/1.73 m2 

    Study Design

    A double-blind, placebo- and active-controlled study of 1284 patients who were inadequately controlled on metformin alone. Study consisted of a 2-week, single-blind, placebo run-in period, a 26-week, placebo- and active-controlled treatment period (period 1) followed by a 26-week, active-controlled treatment period (period 2). Patients were randomized to the addition of canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo. The primary endpoint was the change in A1C from baseline through week 26; change in A1C from baseline through week 52 was a prespecified secondary endpoint.1 

    Learn about BODY WEIGHT CHANGE

    See the results of INVOKANA® AS MONOTHERAPY, VS JANUVIA®, VS GLIMEPIRIDE, in PATIENTS WITH RENAL IMPAIRMENT, and in OLDER PATIENTS.

    References: 1.  Lavalle-González FJ, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56:2582-2592. Supplemental tables available at: http://link.springer.com/article/10.1007%2Fs00125-013-3039-1. Accessed September 1, 2016. 2. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38(1):140-149. 3. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.