and safety of INVOKANA in combination with insulin. The mean age was 63 years, 66% of patients were men, and the mean baseline eGFR was 75 mL/min/1.73 m2. Patients on basal, bolus, or basal/bolus insulin for at least 10 weeks entered a 2-week, single-blind, placebo run-in period. Approximately 70% of patients were on a background basal/bolus insulin regimen. After the run-in period, patients were randomized to INVOKANA 100 mg, INVOKANA 300 mg, or placebo, administered once daily as add-on to insulin. The mean daily insulin dose at baseline was 83 units, which was similar across treatment groups.
At the of 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 insulin. INVOKANA 100 mg and 300 mg once daily also resulted in a greater proportion of patients achieving an HbA1C less than 7%, in significant reductions in fasting plasma glucose (FPG), and in percent body weight reductions compared to placebo (see Table 14). Statistically significant (p<0.001 for both doses) mean changes from baseline in systolic blood pressure relative to placebo were -2.6 mmHg and -4.4 mmHg with INVOKANA 100 mg and 300 mg, respectively.
Table 14: Results from 18−Week Placebo-Controlled Clinical Study of INVOKANA in Combination with Insulin ≥ 30 Units/Day (With or Without Other Oral Antihyperglycemic Agents)*
Efficacy Parameter Placebo + Insulin(N=565) INVOKANA 100 mg + Insulin(N=566) INVOKANA 300 mg + Insulin(N=587)
* 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) 8.20 8.33 8.27
Change from baseline (adjusted mean) 0.01 -0.63 -0.72
Difference from placebo (adjusted mean) (95% CI) † -0.65‡(-0.73, -0.56) -0.73‡(-0.82, -0.65)
Percent of patients achieving HbA1C < 7% 8 20‡ 25‡
Fasting Plasma Glucose (mg/dL)
Baseline 169 170 168
Change from baseline (adjusted mean) 4 -19 -25
Difference from placebo (adjusted mean) (97.5% CI) † -23‡(-29, -16) -29‡(-35,-23)
Body Weight
Baseline (mean) in kg 97.7 96.9 96.7
% change from baseline (adjusted mean) 0.1 -1.8 -2.3
Difference from placebo (adjusted mean) (97.5% CI) † -1.9‡(-2.2, -1.5) -2.4‡(-2.8, -2.0)
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
14.3 Studies in Special PopulationsAdults 55 to 80 Years of Age
A total of 714 older patients with type 2 diabetes inadequately controlled on current diabetes therapy (either diet and exercise alone or in combination with oral or parenteral agents) participated in a 26-week, double-blind, placebo-controlled study to eva luate the efficacy and safety of INVOKANA in combination with current diabetes treatment. The mean age was 64 years, 55% of patients were men, and the mean baseline eGFR was 77 mL/min/1.73 m2. Patients were randomized to the addition of INVOKANA 100 mg, INVOKANA 300 mg, or placebo, administered once daily. At the end of treatment, INVOKANA provided statistically significant improvements from baseline relative to placebo in HbA1C (p<0.001 for both doses) o |
