In a monotherapy study of patients with T2D who were inadequately controlled on diet and exercise,

Overall incidence of adverse events and incidence of hypoglycemia were comparable in patients receiving INVOKANA® vs placebo1,2

  Placebo
(n=192)
INVOKANA®
100 mg (n=195)
INVOKANA®
300 mg (n=197)
Overall safety and select adverse events with
INVOKANA® monotherapy vs placebo over 26 weeks1,2
Any adverse event (AE) 52.6% 61.0% 59.9%
AEs related to study drug* 9.4% 17.4% 25.4%
Serious AEs related to study drug* 0% 1.5% 0%
Urinary tract infection 4.2% 7.2% 5.1%
Hypoglycemia 2.6% 3.6% 3.0%
Genital mycotic infection
Male 0% 2.5% 5.6%
Female 3.8% 8.8% 7.4%
Osmotic diuresis–related AEs
Increased urine frequency 0.5% 2.6% 3.0%
Increased urine volume 0% 0% 3.0%
Volume-related AEs
Postural dizziness 0% 0.5% 1.0%
Orthostatic hypotension 0% 0% 1.0%

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

T2D=type 2 diabetes.

 

Monotherapy vs placebo + diet and exercise at 26 weeks

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