Author (Year) | Study Design | Subjects | Methods | Results | |||
Ferrannini (2013) | Randomized Double-blind Placebo- controlled | 406 T2DM (211M; 195F) | Screening Period: up to 1 week (2 visits)
Oral AHA Washout Period (if applicable): 4 weeks
Open-label Placebo Run-in Period: 2 weeks
Double-blind Treatment Period: 12 weeks
Group A: placebo once daily
Group B: EMPA 5 mg once daily
Group C: EMPA10 mg once daily
Group D: EMPA 25 mg once daily
Group E: Open-label MET (up to 1000 mg twice daily or maximum tolerated dose)
Follow-up Visit: 4 - 7 days after last treatment | HbA1C (%) at 12 Weeks | |||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | |||||
(95% CI) | (95% CI) | ||||||
PBO | 7.8 ± 0.8 | 0.1 | - | ||||
(N = 82) | (−0.09, 0.27) | ||||||
EMPA 5 mg | 7.9 ± 0.8 | 0.4* | - | ||||
(N = 81) | (−0.61, −0.25) | ||||||
EMPA 10 mg | 8.0 ± 0.8 | −0.5* | - | ||||
−81 | (−0.66, −0.30) | ||||||
EMPA 25 mg | 7.8 ± 0.8 | −0.6* | - | ||||
(N = 82) | (−0.81, −0.45) | ||||||
MET | 8.1 ± 0.9 | −0.7* | - | ||||
(N = 80) | (−0.92, −0.57) | ||||||
*p < 0.0001 vs. PBO | |||||||
FPG (mg/dL) at 12 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | |||||
(95% CI) | (95% CI) | ||||||
PBO | 171.2 ± 39.6 | 0.7 | - | ||||
(N = 82) | (−6.3, 7.7) | ||||||
EMPA 5 mg | 178.4 ± 45.0 | −23.2* | - | ||||
(N = 81) | (−30.5, −16.2) | ||||||
EMPA 10 mg | 178.4 ± 46.8 | −29.0* | - | ||||
−81 | (−36.0, −21.8) | ||||||
EMPA 25 mg | 171.2 ± 25.2 | −31.0* | - | ||||
(N = 82) | (−38.2, −24.1) | ||||||
MET | 176.6 ± 43.2 | −29.9* | - | ||||
(N = 80) | (−38.0, −21.8) | ||||||
Body Weight (kg) at 12 Weeks | |||||||
Baseline Mean | Adjusted Mean Change | Difference vs. PBO | |||||
(95% CI) | (95% CI) | ||||||
PBO | 82.2 | −0.75 | - | ||||
(N = 82) | (−1.26, −0.23) | ||||||
EMPA 5 mg | 82.8 | −1.81 | - | ||||
(N = 81) | (−2.32, −1.29) | ||||||
EMPA 10 mg | 76.8 | −2.33 | - | ||||
−81 | (−2.84, −1.82) | ||||||
EMPA 25 mg | 81.2 | −2.03 | - | ||||
(N = 82) | (−2.54, −1.52) | ||||||
MET | 81.1 | −1.32 | - | ||||
(N = 80) | (−1.84, −0.81) |