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INVOKANA® 300 mg demonstrated superior reductions in A1C* vs Januvia® 100 mg and helped to get more patients to goal in 2 studies1-3

In patients inadequately controlled on metformin + a sulfonylurea

  • In a prespecified analysis, superiority was determined once noninferiority was confirmed2*

Adjusted Mean Change in A1C From Baseline at 52 Weeks (%)1

 


Lower A1C levels in clinical trial results: INVOKANA® vs Januvia®Lower A1C levels in clinical trial results: INVOKANA® vs Januvia®
  • INVOKANA® 300 mg difference from Januvia® 100 mg: –0.37% (95% CI: –0.50, –0.25; P <0.05)

*Noninferiority of INVOKANA® + metformin and a sulfonylurea to Januvia® + metformin and a sulfonylurea was assessed based on a prespecified margin of 0.3% for the upper limit of the 2-sided 95% CI for the comparison in the primary last observation carried forward analysis. If noninferiority was demonstrated, then superiority was assessed, as determined by an upper bound of the 95% CI around the between-group difference (INVOKANA® minus Januvia®) of <0.0%.2

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.3

Adjusted mean change in A1C with INVOKANA® 300 mg vs Januvia® 100 mg by baseline A1C subgroup2

In patients inadequately controlled on metformin + a sulfonylurea

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

 


Adjusted Mean Change in A1C by Baseline A1C Subgroup at 52 Weeks Adjusted Mean Change in A1C by Baseline A1C Subgroup at 52 Weeks

§A1C <8.0%: Januvia® 100 mg (n=174), INVOKANA® 300 mg (n=185);
A1C 8.0% to <9.0%: Januvia® 100 mg (n=122), INVOKANA® 300 mg (n=125);
A1C ≥9.0%: Januvia® 100 mg (n=82), INVOKANA® 300 mg (n=67).2

Secondary endpoint: Percent of patients who achieved the A1C goal of <7.0% vs Januvia® 100 mg at 52 weeks1,4

  • 48% with INVOKANA® 300 mg + metformin and a sulfonylurea
  • 35% with Januvia® 100 mg + metformin and a sulfonylurea

The recommended starting dose of INVOKANA® is 100 mg once daily. In patients tolerating the starting dose who have an eGFR ≥60 mL/min/1.73 m2 and require additional glycemic control, the dose can be increased to 300 mg once daily.1

INVOKANA® should not be initiated in patients with an eGFR <45 mL/min/1.73 m2.

In a second trial, INVOKANA® 100 mg and 300 mg achieved significantly greater reductions in A1C vs placebo at 26 weeks, in patients inadequately controlled on metformin3

Secondary endpoint: INVOKANA® 100 mg and 300 mg achieved similar and superior reductions, respectively, in A1C vs Januvia® 100 mg at 52 weeks, in patients inadequately controlled on metformin3

Adjusted Mean Change in A1C From Baseline (%)


Adjusted mean change in A1C clinical trial results: INVOKANA® vs Januvia®

The primary endpoint was the change in A1C vs placebo from baseline through week 26; change in A1C vs Januvia® was a prespecified secondary endpoint at week 52.3

Secondary endpoint: Percent of patients who achieved the A1C goal of <7.0% vs Januvia® 100 mg at 52 weeks3,4

  • 41.4% with INVOKANA® 100 mg + metformin
  • 54.7% with INVOKANA® 300 mg + metformin
  • 50.6% with Januvia® 100 mg + metformin

Study Designs

INVOKANA® vs Januvia® in patients inadequately controlled on metformin + a sulfonylurea
A randomized, double-blind, active-controlled 52-week study of 755 patients with type 2 diabetes who were inadequately controlled on maximum doses of metformin (≥2000 mg/day, or ≥1500 mg/day if higher dose not tolerated) and near maximally or maximally effective doses of a sulfonylurea. Patients received Januvia® 100 mg (n=378) once daily or INVOKANA® 300 mg (n=377) once daily, each in combination with metformin + a sulfonylurea. Mean baseline A1C values were, respectively, 8.13% and 8.12%. The primary endpoint was the change in A1C from baseline to week 52. Prespecified secondary endpoints included change in fasting plasma glucose, percent change in body weight, and change in systolic blood pressure. Additional efficacy endpoints included percent of patients with A1C <7.0%.1,2

INVOKANA® vs Januvia® in patients inadequately controlled on metformin
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 INVOKANA® 100 mg, INVOKANA® 300 mg, Januvia® 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. 3

Learn about FASTING PLASMA GLUCOSE CHANGE

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

References: 1. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial [published correction appears in Diabetes Care. 2013;36(12):4172]. Diabetes Care. 2013;36(9):2508-2515. 3. 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. 4. 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.