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INVOKANA® demonstrated greater reductions in fasting plasma glucose (FPG) vs glimepiride at 52 weeks, with reductions at 104 weeks1-4
In patients inadequately controlled on metformin
Secondary Endpoint: Adjusted Mean Change in FPG From Baseline at 52 Weeks (mg/dL)1,2,4
*95% CI: –10, –2. †95% CI: –13, –5.
‡Mean daily dose=5.6 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.
Secondary Endpoint: Adjusted Mean Change in FPG From Baseline at 104 Weeks (mg/dL)3,4
§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.
SELECT IMPORTANT SAFETY INFORMATION FROM PRESCRIBING INFORMATION
- In 4 pooled 26-week placebo-controlled trials, the most commonly reported adverse events (≥5%) were female genital mycotic infection, urinary tract infection, and increased urination1||
||The 4 placebo-controlled trials included 1 monotherapy trial and 3 add-on combination trials with metformin, metformin + a sulfonylurea, or metformin + pioglitazone.
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.3