n systolic blood pressure relative to placebo were -5.4 mmHg and -6.6 mmHg with INVOKANA 100 mg and 300 mg, respectively.
Table 8: Results from 26-Week Placebo-Controlled Clinical Study of INVOKANA in Combination with Metformin * Efficacy Parameter Placebo + Metformin(N=183) INVOKANA 100 mg + Metformin(N=368) INVOKANA 300 mg + Metformin(N=367)
* Intent-to-treat population using last observation in study prior to glycemic rescue therapy
Least squares mean adjusted for baseline value and stratification factors
p<0.001
HbA1C (%)
Baseline (mean) 7.96 7.94 7.95
Change from baseline (adjusted mean) -0.17 -0.79 -0.94
Difference from placebo (adjusted mean) (95% CI) † -0.62‡(-0.76, -0.48) -0.77‡(-0.91, -0.64)
Percent of patients achieving HbA1C < 7% 30 46‡ 58‡
Fasting Plasma Glucose (mg/dL)
Baseline (mean) 164 169 173
Change from baseline (adjusted mean) 2 -27 -38
Difference from placebo (adjusted mean) (95% CI) † -30‡(-36, -24) -40‡(-46, -34)
2-hour Postprandial Glucose (mg/dL)
Baseline (mean) 249 258 262
Change from baseline (adjusted mean) -10 -48 -57
Difference from placebo (adjusted mean) (95% CI) † -38‡(-49, -27) -47‡(-58, -36)
Body Weight
Baseline (mean) in kg 86.7 88.7 85.4
% change from baseline (adjusted mean) -1.2 -3.7 -4.2
Difference from placebo (adjusted mean) (95% CI) † -2.5‡(-3.1, -1.9) -2.9‡(-3.5, -2.3)
Intent-to-treat population using last observation in study prior to glycemic rescue therapy
Least squares mean adjusted for baseline value and stratification factors
p<0.001
INVOKANA Compared to Glimepiride, Both as Add-on Combination With Metformin
A total of 1450 patients with type 2 diabetes inadequately controlled on metformin monotherapy (greater than or equal to 2,000 mg/day, or at least 1,500 mg/day if higher dose not tolerated) participated in a 52-week, double-blind, active-controlled study to eva luate the efficacy and safety of INVOKANA in combination with metformin.
The mean age was 56 years, 52% of patients were men, and the mean baseline eGFR was 90 mL/min/1.73 m2. Patients tolerating maximally required metformin dose (N=928) were randomized after completing a 2-week, single-blind, placebo run-in period. Other patients (N=522) were switched to metformin monotherapy (at doses described above) for at least 10 weeks, then completed a 2-week single-blind run-in period. After the 2-week run-in period, patients were randomized to INVOKANA 100 mg, INVOKANA 300 mg, or glimepiride (titration allowed throughout the 52-week study to 6 or 8 mg), administered once daily as add-on therapy to metformin.
As shown in Table 9 and Figure 1, at the end of treatment, INVOKANA 100 mg provided similar reductions in HbA1C from baseline compared to glimepiride when added to metformin therapy. INVOKANA 300 mg provided a greater reduction from baseline in HbA1C compared to glimepiride, and the relative treatment difference was -0.12% (95% CI: −0.22; −0.02). As shown in Table 9, treatment with INVOKANA 100 mg and 300 mg daily provided greater improvements in percent body weight change, relative to glimepiride.
Table 9: Results from 52−Week Clinical Study Comparing INVOKANA to Glimepiride in Combination with Metformin *
Efficacy Parameter INVOKANA 100 mg + M |
