With INVOKANA® 300 mg:

consistent ~1% A1C reductions, along with body weight and systolic blood pressure reductions, can change the conversation with your patients1-4

The only SGLT2 inhibitor to demonstrate superior A1C (at 300 mg),* body weight, and systolic blood pressure reductions vs Januvia® (sitagliptin)† and vs glimepiride‡

Adjusted mean change in A1C from baseline (%)1-4

Triple therapy vs Januvia® + metformin and SU at 52 weeks

  • INVOKANA® 300 mg difference from Januvia® 100 mg: –0.37% (95% CI: –0.50, –0.25); P<0.05

Dual therapy vs glimepiride + metformin at 52 weeks

  • INVOKANA® 100 mg difference from glimepiride: –0.01% (95% CI: –0.11, 0.09)
  • INVOKANA® 300 mg difference from glimepiride: –0.12% (95% CI: –0.22, –0.02)

Monotherapy vs placebo + diet and exercise at 26 weeks

  • INVOKANA® 100 mg difference from placebo: –0.91% (95% CI: –1.09, –0.73); P<0.001
  • INVOKANA® 300 mg difference from placebo: –1.16% (95% CI: –1.34, –0.99); P<0.001

The recommended starting dose of INVOKANA® is 100 mg once daily.1

INVOKANA® is not indicated for weight loss or as an antihypertensive treatment.

*In a prespecified analysis, superiority was determined once noninferiority was confirmed. Noninferiority of INVOKANA® + metformin and a sulfonylurea to Januvia® + metformin and a sulfonylurea was assessed based on a prespecified margin of 0.3% for the upper limit of the 2-sided 95% CI for the comparison in the primary last observation carried forward analysis. If noninferiority was demonstrated, then superiority was assessed, as determined by an upper bound of the 95% CI around the between-group difference (INVOKANA® minus Januvia®) of <0.0%.2

Assessment of noninferiority of INVOKANA® to glimepiride was based on a prespecified noninferiority margin of 0.3%. If noninferiority was shown, the protocol specified a step-down assessment of superiority on the basis of an upper bound of the 95% CI for the difference of each INVOKANA® dose vs glimepiride of less than 0.0%.3

INVOKANA® 300 mg vs Januvia® 100 mg.

Glimepiride with a mean daily dose of 5.6 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.

SGLT2=sodium-glucose co-transporter 2.

Indicated trademarks are registered trademarks of their respective owners.

Secondary endpoint: adjusted mean change in body weight from baseline (%)1-4

Triple therapy vs Januvia® + metformin and SU at 52 weeks

  • INVOKANA® 300 mg difference from Januvia® 100 mg: –2.8% (–5.3 lb) (95% CI: –3.3, –2.2); P<0.001

Dual therapy vs glimepiride + metformin at 52 weeks

  • INVOKANA® 100 mg difference from glimepiride: –5.2% (–9.7 lb) (95% CI: –5.7, –4.7); P<0.001
  • INVOKANA® 300 mg difference from glimepiride: –5.7% (–10.4 lb) (95% CI: –6.2, –5.1); P<0.001

Monotherapy vs placebo + diet and exercise at 26 weeks

  • INVOKANA® 100 mg difference from placebo: –2.2% (–4.2 lb) (95% CI: –2.9, –1.6); P<0.001
  • INVOKANA® 300 mg difference from placebo: –3.3% (–6.4 lb) (95% CI: –4.0, –2.6); P<0.001

The recommended starting dose of INVOKANA® is 100 mg once daily.1

INVOKANA® is not indicated for weight loss or as an antihypertensive treatment.

INVOKANA® 300 mg vs Januvia® 100 mg.

Glimepiride with a mean daily dose of 5.6 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.

SGLT2=sodium-glucose co-transporter 2.

Indicated trademarks are registered trademarks of their respective owners.

Secondary endpoint: adjusted mean change in systolic blood pressure from baseline (mm Hg)1-4

Triple therapy vs Januvia® + metformin and SU at 52 weeks

  • INVOKANA® 300 mg difference from Januvia® 100 mg: –5.9 mm Hg (95% CI: –7.6, –4.2); P<0.001

Dual therapy vs glimepiride + metformin at 52 weeks

  • INVOKANA® 100 mg difference from glimepiride: –3.5 mm Hg (95% CI: –4.9, –2.1)
  • INVOKANA® 300 mg difference from glimepiride: –4.8 mm Hg (95% CI: –6.2, –3.4)

Monotherapy vs placebo + diet and exercise at 26 weeks

  • INVOKANA® 100 mg difference from placebo: –3.7 mm Hg (95% CI: –5.9, –1.6); P<0.001
  • INVOKANA® 300 mg difference from placebo: –5.4 mm Hg (95% CI: –7.6, –3.3); P<0.001

The recommended starting dose of INVOKANA® is 100 mg once daily.1

INVOKANA® is not indicated for weight loss or as an antihypertensive treatment.

INVOKANA® 300 mg vs Januvia® 100 mg.

Glimepiride with a mean daily dose of 5.6 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.

SGLT2=sodium-glucose co-transporter 2.

Indicated trademarks are registered trademarks of their respective owners.

Triple therapy vs Januvia® + metformin and SU at 52 weeks (Schernthaner et al)

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%.1,2

Dual therapy vs glimepiride + metformin at 52 weeks (Cefalu et al)

The efficacy and safety of INVOKANA® were compared with glimepiride in 1450 patients on stable doses of metformin (≥2000 mg/day, or ≥1500 mg/day if higher dose not tolerated). In this 52-week, double-blind, active-controlled study, patients were randomized to receive glimepiride (titration allowed throughout the 52-week study up to 6 mg or 8 mg [mean daily dose=5.6 mg]) + metformin (n=482), INVOKANA® 100 mg + metformin (n=483), or INVOKANA® 300 mg + metformin (n=485), administered once daily. Mean baseline A1C values were, respectively, 7.83%, 7.78%, and 7.79%. The primary endpoint was the change in A1C from baseline to week 52. Prespecified secondary endpoints included percent change in body weight, change in systolic blood pressure, and the proportion of patients with documented hypoglycemic episodes.1,3

Monotherapy vs placebo + diet and exercise at 26 weeks (Stenlöf et al)

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.1,4

References: 1. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. 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. 3. Cefalu WT, Leiter LA, Yoon K-H, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013;382(9896):941-950. 4. 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.