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INVOKANA® demonstrated superior reductions in body weight vs glimepiride at 52 weeks, with reductions at 104 weeks1-4
In patients inadequately controlled on metformin
Secondary Endpoint: Adjusted Mean Change in Body Weight From Baseline at 52 Weeks (%)1-3
‡Mean daily dose=5.6 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.
INVOKANA® is not indicated for weight loss.
Secondary Endpoint: Adjusted Mean Change in Body Weight From Baseline at 104 Weeks (%)4
§Mean maximum dose=5.8 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.
Note: No prespecified statistical analysis was conducted at 104 weeks to compare differences in glimepiride, INVOKANA® 100 mg, and INVOKANA® 300 mg.
Secondary endpoint: Percentage of patients with type 2 diabetes who experienced ≥5% body weight reductions at 52 weeks with INVOKANA® vs glimepiride3
- 33% with INVOKANA® 100 mg + metformin
- 43% with INVOKANA® 300 mg + metformin
- 6% with glimepiride + metformin
SELECT IMPORTANT SAFETY INFORMATION
- UGT Enzyme Inducers: Rifampin: Co-administration of INVOKANA® with rifampin decreased INVOKANA® area under the curve (AUC) by 51% and therefore may decrease efficacy. If an inducer of UGT enzymes must be co-administered with INVOKANA®, consider increasing the dose to 300 mg once daily if patients are currently tolerating INVOKANA® 100 mg once daily, have an eGFR ≥60 mL/min/1.73 m2, and require additional glycemic control. Consider other antihyperglycemic therapy in patients with an eGFR <60 mL/min/1.73 m2 who require additional glycemic control.
INVOKANA® vs glimepiride over 52 weeks
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 and the proportion of patients with documented hypoglycemic episodes.1,2
INVOKANA® vs glimepiride over 104 weeks
This randomized, double-blind, active-controlled study consisted of an initial core period, followed by a double-blind extension period of 52 weeks. 1151 patients who completed the 52-week core study entered the second period and continued on the treatments to which they had been randomized. Glimepiride titration was continued throughout the extension period (final mean daily dose=5.6 mg). Secondary endpoints assessed at week 104 included change in A1C, fasting plasma glucose, systolic blood pressure, percent change in body weight, and the proportion of patients who achieved A1C <7.0%. No prespecified hypothesis testing was conducted at week 104; thus, P values were not reported but 95% confidence intervals were reported.4