You are here

INVOKANA® has been studied in more than 20,000 patients with type 2 diabetes across 15 completed and ongoing double-blind clinical trials1

STUDIED AS MONOTHERAPY

A 26-week trial vs placebo2,3

2 Studies vs Januvia®
Two 52-week studies vs Januvia® 100 mg
  • Study 1: In patients inadequately controlled on metformin + a sulfonylurea2,4
  • Secondary endpoint in study 2: In patients inadequately controlled on metformin5
Studied vs Glimepiride
A 52-week study vs glimepiride, followed by a 52-week extension, in patients inadequately controlled on metformin2,6,7
STUDIED IN PATIENTS WITH TYPE 2 DIABETES WITH MODERATE RENAL IMPAIRMENT
A dedicated 26-week placebo-controlled study in patients with moderate renal impairment (eGFR 30 to <50 mL/min/1.73 m2) who were either not on antihyperglycemic (AHA) therapy or were on a stable AHA regimen2,8
STUDIED IN OLDER PATIENTS WITH TYPE 2 DIABETES
A 26-week placebo-controlled study of patients aged 55 to 80 years who were inadequately controlled on diet and exercise alone or in combination with AHA therapy, followed by a 78-week placebo-controlled, double-blind extension in patients inadequately controlled on a stable AHA regimen2,9,10

INVOKANA® has been studied in placebo-controlled trials as monotherapy and in combination with2:

  • Metformin
  • A sulfonylurea
  • Metformin + a sulfonylurea
  • Metformin + pioglitazone
  • Insulin (with or without other AHAs, including metformin)

Additional safety studies were conducted in these patient populations2,8-10,11:

  • Patients with moderate renal impairment (eGFR 30 to <50 mL/min/1.73 m2)
  • Older patients (aged 55 to 80 years)*
  • Patients with or at risk for cardiovascular disease (ongoing)

In 3 comparative trials2,5:

  • 2 vs Januvia®
    • 1 in combination with metformin
    • 1 in combination with metformin + a sulfonylurea
  • 1 vs glimepiride (in combination with metformin)

Reductions in A1C were observed across subgroups, including2:

  • Age
  • Gender
  • Race
  • Baseline body mass index

INVOKANA® Phase 3 Clinical Trial Program Overview1-11

Monotherapy Dual combination therapy Triple combination therapy Insulin +/- AHAs
26-week monotherapy vs placebo 26-week add-on to metformin vs placebo and 52-week add-on to metformin vs Januvia® 26-week add-on to metformin + a sulfonylurea vs placebo 18-week add-on to insulin vs placebo
  52-week add-on to metformin vs glimepiride 26-week add-on to metformin + pioglitazone vs placebo  
  18-week add-on to a sulfonylurea vs placebo 52-week add-on to metformin + a sulfonylurea vs Januvia®  
Specific safety studies

Older patients:
 104-week study in patients aged 55 to 80 years*

Moderate renal impairment:
 26-week study of patients with moderate renal impairment (eGFR 30 to <50 mL/min/1.73 m2)

CANVAS:
 Ongoing study of cardiovascular safety

*In combination with diet and exercise alone or with current antihyperglycemic agents.

Patients were randomized to INVOKANA® 100 mg, INVOKANA® 300 mg, Januvia® 100 mg, or placebo, administered once daily.

References: 1. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 3. 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. 4. 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. Supplementary tables available at: http://care.diabetesjournals.org/content/36/9/2508/suppl/DC1. Accessed September 1, 2016. 5. 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. 6. Cefalu WT, Leiter LA, Yoon K-H, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013;382(9896):941-950. 7. Leiter LA, Yoon K-H, Arias P, et al. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015;38(3):355-364. 8. Yale JF, Bakris G, Cariou B, et al. Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2013;15(5):463-473. 9. Bode B, Stenlöf K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013;41(2):72-84. 10. Bode B, Stenlöf K, Harris S, et al. Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 55-80 years with type 2 diabetes. Diabetes Obes Metab. 2015;17(3):294-303. 11. Neal B, Perkovic V, de Zeeuw D, et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—a randomized placebo-controlled trial. Am Heart J. 2013;166(2):217-223.e11.