etformin(N=483) INVOKANA 300 mg + Metformin(N=485) Glimepiride (titrated) + Metformin(N=482)
*Intent-to-treat population using last observation in study prior to glycemic rescue therapy
Least squares mean adjusted for baseline value and stratification factors
INVOKANA + metformin is considered non-inferior to glimepiride + metformin because the upper limit of this confidence interval is less than the pre-specified non-inferiority margin of < 0.3%.
p<0.001
HbA1C (%)
Baseline (mean) 7.78 7.79 7.83
Change from baseline (adjusted mean) -0.82 -0.93 -0.81
Difference from glimepiride (adjusted mean) (95% CI) † -0.01‡(-0.11;0.09) -0.12‡(-0.22;-0.02)
Percent of patients achieving HbA1C < 7% 54 60 56
Fasting Plasma Glucose (mg/dL)
Baseline (mean) 165 164 166
Change from baseline (adjusted mean) -24 -28 -18
Difference from glimepiride (adjusted mean) (95% CI) † -6(-10;-2) -9(-13;-5)
Body Weight
Baseline (mean) in kg 86.8 86.6 86.6
% change from baseline (adjusted mean) -4.2 -4.7 1.0
Difference from glimepiride (adjusted mean) (95% CI) † -5.2§(-5.7; -4.7) -5.7§(-6.2; -5.1)
Intent-to-treat population using last observation in study prior to glycemic rescue therapy
Least squares mean adjusted for baseline value and stratification factors
INVOKANA + metformin is considered non-inferior to glimepiride + metformin because the upper limit of this confidence interval is less than the pre-specified non-inferiority margin of < 0.3%.
p<0.001
Figure 1: Mean HbA1C Change at Each Time Point (Completers) and at Week 52 Using Last Observation Carried Forward (mITT Population)
Add-on Combination Therapy With Sulfonylurea
A total of 127 patients with type 2 diabetes inadequately controlled on sulfonylurea monotherapy participated in an 18-week, double-blind, placebo-controlled sub-study to eva luate the efficacy and safety of INVOKANA in combination with sulfonylurea. The mean age was 65 years, 57% of patients were men, and the mean baseline eGFR was 69 mL/min/1.73 m2. Patients treated with sulfonylurea monotherapy on a stable protocol-specified dose (greater than or equal to 50% maximal dose) for at least 10 weeks completed a 2-week, single-blind, placebo run-in period. After the run-in period, patients with inadequate glycemic control were randomized to INVOKANA 100 mg, INVOKANA 300 mg, or placebo, administered once daily as add-on to sulfonylurea.
As shown in Table 10, at the end of treatment, INVOKANA 100 mg and 300 mg daily provided statistically significant (p<0.001 for both doses) improvements in HbA1C relative to placebo when added to sulfonylurea. INVOKANA 300 mg once daily compared to placebo resulted in a greater proportion of patients achieving an HbA1C less than 7%, (33% vs 5%), greater reductions in fasting plasma glucose (-36 mg/dL vs +12 mg/dL), and greater percent body weight reduction (-2.0% vs -0.2%).
Table 10: Results from 18-Week Placebo−Controlled Clinical Study of INVOKANA in Combination with Sulfonylurea *
Table 10: Results from 18-Week Placebo−Controlled Clinical Study of INVOKANA in Combination with Sulfonylurea * Efficacy Parameter Placebo + Sulfonylurea(N=45) INVOKANA 100 mg + Sulfonylurea(N=42) INVOKANA 300 mg + Sulfonylurea(N=40)
* Intent-to-treat population using last observation in study pri |
