canagliflozin + metformin demonstrated a similar overall tolerability profile and incidence of hypoglycemia to sitagliptin 100 mg + metformin1,2

Overall safety and select adverse events over 52 weeks1,2

 

Sitagliptin 100 mg + metformin (n=366)

Canagliflozin 100 mg + metformin (n=368)

Canagliflozin 300 mg + metformin (n=367)

 

Overall Incidence

Discontinuation Rate

Overall Incidence

Discontinuation Rate

Overall Incidence

Discontinuation Rate

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%

Osmotic diuresis–related AEs

 

 

 

 

 

 

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%

Volume-related AEs

 

 

 

 

 

 

Postural dizziness

0.3%

0%

0.5%

0%

0.5%

0%

Orthostatic hypotension

0%

0%

0%

0%

0.3%

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

Dual therapy vs placebo + metformin at 26 weeks and vs sitagliptin + metformin at 52 weeks (Lavalle-González et al)

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

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 October 30, 2018. 2. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.