SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(二十六)
gliflozin 10 mg or 25 mg daily provided statistically significant reductions in HbA1c (p-value <0.0001), FPG, and body weight compared with placebo (see Table 7).
Table 7 Results at Week 24 From a Placebo-Controlled Study for Empagliflozin used in Combination with Metformin
aModified intent to treat population. Last observation on study (LOCF) was used to impute missing data at Week 24. At Week 24, 9.7%, 14.1%, and 24.6% was imputed for patients randomized to empagliflozin 10 mg, empagliflozin 25 mg, and placebo, respectively.
bANCOVA p-value <0.0001 (HbA1c: ANCOVA model includes baseline HbA1c, treatment, renal function, and region. Body weight and FPG: same model used as for HbA1c but additionally including baseline body weight/baseline FPG, respectively.)
cFPG (mg/dL); for empagliflozin 10 mg, n=216, for empagliflozin 25 mg, n=213, and for placebo, n=207
Empagliflozin
10 mg +
Metformin
N=217 Empagliflozin
25 mg +
Metformin
N=213 Placebo +
Metformin
N=207
HbA1c (%)a
Baseline (mean) 7.9 7.9 7.9
Change from baseline (adjusted mean) -0.7 -0.8 -0.1
Difference from placebo + metformin (adjusted mean) (95% CI) -0.6b (-0.7, -0.4) -0.6b (-0.8, -0.5) --
Patients [n (%)] achieving HbA1c <7% 75 (38%) 74 (39%) 23 (13%)
FPG (mg/dL)c
Baseline (mean) 155 149 156
Change from baseline (adjusted mean) -20 -22 6
Difference from placebo + metformin (adjusted mean) -26 -29 --
Body Weight
Baseline mean in kg 82 82 80
% change from baseline (adjusted mean) -2.5 -2.9 -0.5
Difference from placebo (adjusted mean) (95% CI) -2.0b (-2.6, -1.4) -2.5b (-3.1, -1.9) --
At Week 24, the systolic blood pressure was statistically significantly reduced compared to placebo by -4.1 mmHg (placebo-corrected, p-value <0.0001) for empagliflozin 10 mg and -4.8 mmHg (placebo-corrected, p-value <0.0001) for empagliflozin 25 mg.
Empagliflozin Initial Combination Therapy with Metformin
A total of 1364 patients with type 2 diabetes participated in a double-blind, randomized, active-controlled study to eva luate the efficacy and safety of empagliflozin in combination with metformin as initial therapy compared to the corresponding individual components.
Treatment-naïve patients with inadequately controlled type 2 diabetes entered an open-label placebo run-in for 2 weeks. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10.5% were randomized to one of 8 active-treatment arms: empagliflozin 10 mg or 25 mg; metformin hydrochloride 1000 mg, or 2000 mg; empagliflozin 10 mg in combination with 1000 mg or 2000 mg metformin; or empagliflozin 25 mg in combination with 1000 mg or 2000 mg metformin hydrochloride.
At Week 24, initial therapy of empagliflozin in combination with metformin provided statistically significant reductions in HbA1c (p-value <0.01) compare |
