or to glycemic rescue therapy
Least squares mean adjusted for baseline value
p<0.001
HbA1C (%)
Baseline (mean) 8.49 8.29 8.28
Change from baseline (adjusted mean) 0.04 -0.70 -0.79
Difference from placebo (adjusted mean) (95% CI) † -0.74‡(-1.15, -0.33) -0.83‡(-1.24, -0.41)
Intent-to-treat population using last observation in study prior to glycemic rescue therapy
Least squares mean adjusted for baseline value
p<0.001
Add-on Combination Therapy With Metformin and Sulfonylurea
A total of 469 patients with type 2 diabetes inadequately controlled on the combination of metformin (greater than or equal to 2,000 mg/day or at least 1,500 mg/day if higher dose not tolerated) and sulfonylurea (maximal or near-maximal effective dose) participated in a 26-week, double-blind, placebo-controlled study to eva luate the efficacy and safety of INVOKANA in combination with metformin and sulfonylurea. The mean age was 57 years, 51% of patients were men, and the mean baseline eGFR was 89 mL/min/1.73 m2. Patients already on the protocol-specified doses of metformin and sulfonylurea (N=372) entered a 2-week, single-blind, placebo run-in period. Other patients (N=97) were required to be on a stable protocol-specified dose of metformin and sulfonylurea for at least 8 weeks before entering the 2-week run-in period. Following the run-in period, patients were randomized to INVOKANA 100 mg, INVOKANA 300 mg, or placebo, administered once daily as add-on to metformin and sulfonylurea.
At the end of treatment, INVOKANA 100 mg and 300 mg once daily resulted in a statistically significant improvement in HbA1C (p<0.001 for both doses) compared to placebo when added to metformin and sulfonylurea. INVOKANA 100 mg and 300 mg once daily also resulted in a greater proportion of patients achieving an HbA1C less than 7%, in a significant reduction in fasting plasma glucose (FPG), and in percent body weight reduction compared to placebo when added to metformin and sulfonylurea (see Table 11).
Table 11: Results from 26−Week Placebo-Controlled Clinical Study of INVOKANA in Combination with Metformin and Sulfonylurea *
Efficacy Parameter Placebo + Metformin and Sulfonylurea(N=156) INVOKANA 100 mg + Metforminand Sulfonylurea (N=157) INVOKANA 300 mg + Metforminand Sulfonylurea(N=156)
* 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
A1C (%)
Baseline (mean) 8.12 8.13 8.13
Change from baseline (adjusted mean) -0.13 -0.85 -1.06
Difference from placebo (adjusted mean) (95% CI) † -0.71‡(-0.90;-0.52) -0.92‡(-1.11;-0.73)
Percent of patients achieving A1C < 7% 18 43‡ 57‡
Fasting Plasma Glucose (mg/dL)
Baseline (mean) 170 173 168
Change from baseline (adjusted mean) 4 -18 -31
Difference from placebo (adjusted mean) (95% CI) † -22‡(-31 ,-13) -35‡(-44,-25)
Body Weight
Baseline (mean) in kg 90.8 93.5 93.5
% change from baseline (adjusted mean) -0.7 -2.1 -2.6
Difference from placebo (adjusted mean) (95% CI) † -1.4‡(-2.1;-0.7) -2.0‡(-2.7;-1.3)
Intent-to-treat population using last observation in study prior to glycemic rescue therapy
Least squares mean adjusted for baseline va |
