You are here

INVOKANA® demonstrated superior reductions in fasting plasma glucose (FPG) vs Januvia® 100 mg in 2 studies at 52 weeks1-4

In patients inadequately controlled on metformin + a sulfonylurea

Secondary Endpoint: Adjusted Mean Change in FPG From Baseline at 52 Weeks (mg/dL)1,2,4


Lower fasting plasma glucose levels in clinical trial results: INVOKANA® vs Januvia®


Lower fasting plasma glucose levels in clinical trial results: INVOKANA® vs Januvia®

 

SELECT IMPORTANT SAFETY INFORMATION FROM PRESCRIBING INFORMATION

  • In 4 pooled 26-week placebo-controlled trials, the most commonly reported adverse events (≥5%) were female genital mycotic infection, urinary tract infection, and increased urination1

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

In a second study of patients inadequately controlled on metformin

Secondary Endpoint: Adjusted Mean Change in FPG From Baseline at 52 Weeks (mg/dL)3,4


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


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

The primary endpoint vs placebo 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

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 BODY WEIGHT 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. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.