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Similar overall tolerability profile and incidence of hypoglycemia with INVOKANA® vs  Januvia® 100 mg in 2 studies over 52 weeks1-4

In patients inadequately controlled on metformin + a sulfonylurea

Overall Safety and Select Adverse Events and Discontinuation Rates With INVOKANA® 300 mg vs Januvia® 100 mg Over 52 Weeks1,3,4

  Januvia® 100 mg + metformin and a sulfonylurea (n=378) Discontinuation rate: Januvia® 100 mg + metformin and a sulfonylurea (n=378) INVOKANA® 300 mg + metformin and a sulfonylurea (n=377) Discontinuation rate: INVOKANA® 300 mg + metformin and a sulfonylurea (n=377)
Any AE
77.5% 2.9% 76.7% 5.3%
AEs related to study drug* 27.8% 1.6% 34.0% 3.2%
Serious AEs related to study drug* 0% 0% 0.3% 0.3%
Urinary tract infection 5.6% 0% 4.0% 0.3%
Genital mycotic infection
       
Male 0.5% 0% 9.2% 0.3%
Female 4.3% 0% 15.3% 0%
       
Increased urine frequency 1.3% 0% 1.6% 0.3%
Increased urine volume 0% 0% 0.8% 0.3%
       
Postural dizziness 0.5% 0.3% 0% 0%
Orthostatic hypotension 0.3% 0% 0% 0%
  Januvia® 100 mg + metformin and a sulfonylurea (n=378) INVOKANA® 300 mg + metformin and a sulfonylurea (n=377)
Any AE
77.5% 76.7%
AEs related to study drug* 27.8% 34.0%
Serious AEs related to study drug* 0% 0.3%
Urinary tract infection 5.6% 4.0%
Genital mycotic infection
Male 0.5% 9.2%
Female 4.3% 15.3%
Increased urine frequency 1.3% 1.6%
Increased urine volume 0% 0.8%
Postural dizziness 0.5% 0%
Orthostatic hypotension 0.3% 0%
Discontinuation Rates
Any AE 2.9% 5.3%
AEs related to study drug* 1.6% 3.2%
Serious AEs related to study drug* 0% 0.3%
Urinary tract infection 0% 0.3%
Genital mycotic infection
Male 0% 0.3%
Female 0% 0%
Osmotic diuresis–related AEs
Increased urine frequency 0% 0.3%
Increased urine volume 0% 0.3%
Volume-related AEs
Postural dizziness 0.3% 0%
Orthostatic hypotension 0% 0%

*Possibly, probably, or very likely related to study drug, as assessed by investigators.
Januvia® 100 mg, n=215; INVOKANA® 300 mg, n=207; including balanitis, balanitis Candida, balanoposthitis, genital candidiasis, and genital infection fungal.
Januvia® 100 mg, n=163; INVOKANA® 300 mg, n=170; including vaginal infection, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

Percent of Patients With Documented Hypoglycemia Over 52 Weeks3


Hypoglycemia incidence: INVOKANA® vs Januvia®Hypoglycemia incidence: INVOKANA® vs Januvia®

 

Severe hypoglycemia3:

  • 3.4%: Januvia® 100 mg + metformin and a sulfonylurea
  • 4.0%: INVOKANA® 300 mg + metformin and a sulfonylurea

In a second study of patients inadequately controlled on metformin

Overall Safety and Select Adverse Events and Discontinuation Rates With INVOKANA® vs Januvia® Over 52 Weeks2,4

  Januvia® 100 mg + metformin (n=366) Discontinuation rate: Januvia® 100 mg + metformin (n=366) INVOKANA® 100 mg + metformin (n=368) Discontinuation rate: INVOKANA® 100 mg + metformin (n=368) INVOKANA® 300 mg + metformin (n=367) Discontinuation rate: INVOKANA® 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%
  Januvia® 100 mg + metformin (n=366) INVOKANA® 100 mg + metformin (n=368) INVOKANA® 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.
||Januvia® 100 mg, n=172; INVOKANA® 100 mg, n=174; INVOKANA® 300 mg, n=165; including balanitis, balanoposthitis, and fungal genital infection.
Januvia® 100 mg, n=194; INVOKANA® 100 mg, n=194; INVOKANA® 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 Weeks2


Percent of patients with documented hypoglycemia clinical trial results: INVOKANA® vs Januvia®Percent of patients with documented hypoglycemia clinical trial results: INVOKANA® vs Januvia®

 

Severe hypoglycemia4:

  • 0.3%: Januvia® 100 mg + metformin
  • 0.3%: INVOKANA® 100 mg + metformin
  • 0%: INVOKANA® 300 mg + metformin

SELECT IMPORTANT SAFETY INFORMATION

Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues: INVOKANA® can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANA®.

Study Designs

INVOKANA® vs Januvia® in patients inadequately controlled on metformin + a sulfonylurea
A randomized, double-blind, active-controlled 52-week study of 755 patients with type 2 diabetes who were inadequately controlled on maximum doses of metformin (≥2000 mg/day, or ≥1500 mg/day if higher dose not tolerated) and near maximally or maximally effective doses of a sulfonylurea. Patients received Januvia® 100 mg (n=378) once daily or INVOKANA® 300 mg (n=377) once daily, each in combination with metformin + a sulfonylurea. Mean baseline A1C values were, respectively, 8.13% and 8.12%. The primary endpoint was the change in A1C from baseline to week 52. Prespecified secondary endpoints included change in fasting plasma glucose, percent change in body weight, and change in systolic blood pressure. Additional efficacy endpoints included percent of patients with A1C <7.0%.1,4

INVOKANA® vs Januvia® in patients inadequately controlled on metformin
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 INVOKANA® 100 mg, INVOKANA® 300 mg, Januvia® 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.2

See the results VS GLIMEPIRIDE

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

References: 1. Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial [published correction appears in Diabetes Care. 2013;36(12):4172]. Diabetes Care. 2013;36(9):2508-2515. 2. 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. 3. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 4. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.