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Similar overall incidence of adverse events and incidence of hypoglycemia vs placebo over 26 weeks1-3

Overall Safety and Select Adverse Events and Discontinuation Rates With INVOKANA® vs Placebo Over 26 Weeks1,2

  Placebo (n=192) Discontinuation rate: Placebo (n=192) INVOKANA® 100 mg (n=195) Discontinuation rate: INVOKANA® 100 mg (n=195) INVOKANA® 300 mg (n=197) Discontinuation rate: INVOKANA® 300 mg (n=197)
Any 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%
Genital mycotic infection
           
Male 0% 0% 2.5% 0% 5.6% 0.5%
Female 3.8% 0% 8.8% 0.5% 7.4% 0%
           
Increased urine frequency 0.5% 0% 2.6% 0% 3.0% 0.5%
Increased urine volume 0% 0% 0% 0% 3.0% 0%
           
Postural dizziness 0% 0% 0.5% 0% 1.0% 0%
Orthostatic hypotension 0% 0% 0% 0% 1.0% 0%
  Placebo (n=192) INVOKANA® 100 mg (n=195) INVOKANA® 300 mg (n=197)
Any 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%
Genital mycotic infection
Male 0% 2.5% 5.6%
Female 3.8% 8.8% 7.4%
Increased urine frequency 0.5% 2.6% 3.0%
Increased urine volume 0% 0% 3.0%
Postural dizziness 0% 0.5% 1.0%
Orthostatic hypotension 0% 0% 1.0%
Discontinuation Rates
Any AE 1.0% 3.1% 2.0%
AEs related to study drug* 0% 1.5% 2.0%
Serious AEs related to study drug* 0% 0.5% 0%
Urinary tract infection 0% 0% 0%
Genital mycotic infection
Male 0% 0% 0.5%
Female 0% 0.5% 0%
Osmotic diuresis–related AEs
Increased urine frequency 0% 0% 0.5%
Increased urine volume 0% 0% 0%
Volume-related AEs
Postural dizziness 0% 0% 0%
Orthostatic hypotension 0% 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.

 

Percent of Patients With Documented Hypoglycemia Over 26 Weeks3


Type 2 diabetes patients with documented hypoglycemia: INVOKANA® monotherapy vs placeboType 2 diabetes patients with documented hypoglycemia: INVOKANA® monotherapy vs placebo

 

Study Design

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.1,3

See the results VS JANUVIA®

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

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