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Similar overall tolerability and incidence of hypoglycemia vs sitagliptin + metformin over 52 weeks1,2

Overall Safety and Select Adverse Events and Discontinuation Rates With Canagliflozin + Metformin vs Sitagliptin 100 mg + Metformin Over 52 Weeks1,2

  Sitagliptin 100 mg + metformin (n=366) Discontinuation rate: Sitagliptin 100 mg + metformin (n=366) Canagliflozin 100 mg + metformin (n=368) Discontinuation rate: Canagliflozin 100 mg + metformin (n=368) Canagliflozin 300 mg + metformin (n=367) Discontinuation rate: Canagliflozin 300 mg + metformin (n=367)
Any AE
64.5% 4.4% 72.3% 5.2% 62.7% 3.3%
AEs related to study drug* 19.7% 1.6% 26.4% 3.3% 19.9% 1.4%
Serious AEs related to study drug* 0% 0% 0.3% 0% 0.3% 0.3%
Urinary tract infection 6.3% 0% 7.9% 0% 4.9% 0.3%
Genital mycotic infection
           
Male 1.2% 0% 5.2% 0.6% 2.4% 0%
Female 2.6% 0% 11.3% 0.5% 9.9% 0%
           
Increased urine frequency 0.5% 0% 5.7% 0.3% 3.0% 0.3%
Increased urine volume 0% 0% 0.5% 0.3% 0.5% 0%
           
Postural dizziness 0.3% 0% 0.5% 0% 0.5% 0%
Orthostatic hypotension 0% 0% 0% 0% 0.3% 0%
  Sitagliptin 100 mg + metformin (n=366) Canagliflozin 100 mg + metformin (n=368) Canagliflozin 300 mg + metformin (n=367)
Any AE
64.5% 72.3% 62.7%
AEs related to study drug* 19.7% 26.4% 19.9%
Serious AEs related to study drug* 0% 0.3% 0.3%
Urinary tract infection 6.3% 7.9% 4.9%
Genital mycotic infection
Male 1.2% 5.2% 2.4%
Female 2.6% 11.3% 9.9%
Increased urine frequency 0.5% 5.7% 3.0%
Increased urine volume 0% 0.5% 0.5%
Postural dizziness 0.3% 0.5% 0.5%
Orthostatic hypotension 0% 0% 0.3%
Discontinuation Rates
Any AE 4.4% 5.2% 3.3%
AEs related to study drug* 1.6% 3.3% 1.4%
Serious AEs related to study drug* 0% 0% 0.3%
Urinary tract infection 0% 0% 0.3%
Genital mycotic infection
Male 0% 0.6% 0%
Female 0% 0.5% 0%
Osmotic diuresis–related AEs
Increased urine frequency 0% 0.3% 0.3%
Increased urine volume 0% 0.3% 0%
Volume-related AEs
Postural dizziness 0% 0% 0%
Orthostatic hypotension 0% 0% 0%

All AEs are reported, regardless of rescue medication.
*Possibly, probably, or very likely related to study drug, as assessed by investigators.
Sitagliptin 100 mg, n=172; canagliflozin 100 mg, n=174; canagliflozin 300 mg, n=165; including balanitis, balanoposthitis, and fungal genital infection.
Sitagliptin 100 mg, n=194; canagliflozin 100 mg, n=194; canagliflozin 300 mg, n=202; including vaginal infection, vaginal inflammation, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

Percent of Patients With Documented Hypoglycemia Over 52 Weeks1


Hypoglycemia incidence: canagliflozin 100 mg plus metformin and canagliflozin 300 mg plus metformin vs sitagliptin 100 mg plus metforminHypoglycemia incidence: canagliflozin 100 mg plus metformin and canagliflozin 300 mg plus metformin vs sitagliptin 100 mg plus metformin

Study Design

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 canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 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.1 

See POOLED SAFETY

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

References: 1.  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. 2. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.