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INVOKANA® 300 mg demonstrated superior reductions in A1C* vs glimepiride at 52 weeks, with reductions at 104 weeks1-3
In patients inadequately controlled on metformin
In a prespecified analysis, superiority was determined once noninferiority was confirmed2*
Adjusted Mean Change in A1C From Baseline at 52 Weeks (%)1
*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%.2
†Mean daily dose=5.6 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.
- 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)
Secondary endpoint: Percent of patients who achieved the A1C goal of <7.0% vs glimepiride at 52 weeks1,4
- 54% with INVOKANA® 100 mg + metformin
- 60% with INVOKANA® 300 mg + metformin
- 56% with glimepiride + metformin
Change in A1C with INVOKANA® vs glimepiride at 104 weeks in patients inadequately controlled on metformin3
Secondary Endpoint: Adjusted Mean Change in A1C From Baseline at 104 Weeks (%)
‡Mean maximum dose=5.8 mg. Glimepiride titration up to 6 mg or 8 mg was allowed throughout the study.
Secondary endpoint: Percent of patients who achieved the A1C goal of <7.0% vs glimepiride at 104 weeks3,4
- 43% with INVOKANA® 100 mg + metformin
- 50% with INVOKANA® 300 mg + metformin
- 44% with glimepiride + metformin
INVOKANA® should not be initiated in patients with an eGFR <45 mL/min/1.73 m2 .
Note: No prespecified statistical analysis was conducted at 104 weeks to compare differences in glimepiride, INVOKANA® 100 mg, and INVOKANA® 300 mg.
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