SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(二十七)
d to the individual components (see Table 8).
Table 8 Glycemic Parameters at 24 Weeks in a Study Comparing Empagliflozin and Metformin to the Individual Components as Initial Therapy
aMetformin hydrochloride total daily dose, administered in two equally divided doses per day.
bp-value ≤0.0062 (modified intent to treat population [observed case] MMRM model included treatment, renal function, region, visit, visit by treatment interaction, and baseline HbA1c).
cp-value ≤0.0056 (modified intent to treat population [observed case] MMRM model included treatment, renal function, region, visit, visit by treatment interaction, and baseline HbA1c).
Empagliflozin
10 mg +
Metformin
1000 mga
N=161 Empagliflozin
10 mg +
Metformin
2000 mga
N=167 Empagliflozin
25 mg +
Metformin
1000 mga
N=165 Empagliflozin
25 mg +
Metformin
2000 mga
N=169 Empagliflozin
10 mg
N=169 Empagliflozin
25 mg
N=163 Metformin
1000 mga
N=167 Metformin
2000 mga
N=162
HbA1c (%)
Baseline (mean) 8.7 8.7 8.8 8.7 8.6 8.9 8.7 8.6
Change from baseline (adjusted mean) -2.0 -2.1 -1.9 -2.1 -1.4 -1.4 -1.2 -1.8
Comparison vs empagliflozin (adjusted mean) (95% CI) -0.6b
(-0.9, -0.4) -0.7b
(-1.0, -0.5) -0.6c
(-0.8, -0.3) -0.7c
(-1.0, -0.5) -- -- -- --
Comparison vs metformin (adjusted mean) (95% CI) -0.8b
(-1.0, -0.6) -0.3b
(-0.6, -0.1) -0.8c
(-1.0, -0.5) -0.3c
(-0.6, -0.1) -- -- -- --
Patients [n (%)] achieving HbA1c <7% 96 (63%) 112 (70%) 91 (57%) 111 (68%) 69 (43%) 51 (32%) 63 (38%) 92 (58%)
Empagliflozin Add-On Combination Therapy with Metformin and Sulfonylurea
A total of 666 patients with type 2 diabetes participated in a double-blind, placebo-controlled study to eva luate the efficacy and safety of empagliflozin in combination with metformin plus a sulfonylurea.
Patients with inadequately controlled type 2 diabetes on at least 1500 mg per day of metformin hydrochloride and on a sulfonylurea, entered a 2-week open-label placebo run-in. At the end of the run-in, patients who remained inadequately controlled and had an HbA1c between 7% and 10% were randomized to placebo, empagliflozin 10 mg, or empagliflozin 25 mg.
Treatment with empagliflozin 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 9).
Table 9 Results at Week 24 from a Placebo-Controlled Study for Empagliflozin in Combination with Metformin and Sulfonylurea
aModified intent to treat population. Last observation on study (LOCF) was used to impute missing data at Week 24. At Week 24, 17.8%, 16.7%, and 25.3% 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=225, |
