overall incidence of adverse events and incidence of hypoglycemia vs placebo over 26 weeks1,2

In patients inadequately controlled on diet + exercise

Overall safety and select adverse events and discontinuation rates with INVOKANA® monotherapy vs placebo over 26 weeks1-3
  Placebo
(n=192)
INVOKANA® 100 mg
(n=195)
INVOKANA® 300 mg
(n=197)
  Overall Incidence Discontinuation rate Overall Incidence Discontinuation rate Overall Incidence Discontinuation rate
Any adverse event (AE) 52.6% 1.0% 61.0% 3.1% 59.9% 2.0%
AEs related to study drug* 9.4% 0% 17.4% 1.5% 25.4% 2.0%
Serious AEs related to study drug* 0% 0% 1.5% 0.5% 0% 0%
Urinary tract infection 4.2% 0% 7.2% 0% 5.1% 0%
Hypoglycemia 2.6% 0% 3.6% 0% 3.0% 0%
Genital mycotic infection            
Male† 0% 0% 2.5% 0% 5.6% 0.5%
Female‡ 3.8% 0% 8.8% 0.5% 7.4% 0%
Osmotic diuresis–related AEs            
Increased urine frequency 0.5% 0% 2.6% 0% 3.0% 0.5%
Increased urine volume 0% 0% 0% 0% 3.0% 0%
Volume-related AEs            
Postural dizziness 0% 0% 0.5% 0% 1.0% 0%
Orthostatic hypotension 0% 0% 0% 0% 1.0% 0%

All AEs are reported for regardless of rescue medication, except for osmotic diuresis–related and volume-related AEs, which are reported for before the start of rescue therapy.

*Possibly, probably, or very likely related to study drug, as assessed by investigators.

Placebo, n=88; INVOKANA® 100 mg, n=81; INVOKANA® 300 mg, n=89; including balanitis, balanitis Candida, balanoposthitis, and genital infection fungal.

Placebo, n=104; INVOKANA® 100 mg, n=114; INVOKANA® 300 mg, n=108; including vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

Monotherapy vs placebo + diet and exercise at 26 weeks (Stenlöf et al)

The efficacy and safety of INVOKANA® monotherapy were assessed in subjects with type 2 diabetes mellitus who were inadequately controlled with diet and exercise. In this 26-week, double-blind, placebo-controlled study, 584 patients were randomized to receive placebo (n=192), INVOKANA® 100 mg (n=195), or INVOKANA® 300 mg (n=197). Mean baseline A1C values were, respectively, 7.97%, 8.06%, and 8.01%. The primary endpoint was the change in A1C from baseline to week 26. Prespecified secondary endpoints included change in fasting plasma glucose, change in percent body weight, and change in systolic blood pressure.1,2

References: 1. 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. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 3. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.