QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(三十二)
rtion of patients achieving an HbA1c<7%, compared to dapagliflozin plus metformin or saxagliptin plus metformin (see Table 12).
Table 12: HbA1c Results at Week 24 with the Combination of 10 mg Dapagliflozin and5 mg Saxagliptin plus Metformin*
Efficacy Parameter
10 mg Dapagliflozin and 5 mg Saxagliptin + Metformin
10 mg Dapagliflozin and
5 mg Saxagliptin
+
Metformin
10 mg Dapagliflozin
+
Metformin
5 mg Saxagliptin
+
Metformin
N† 179 179 176
Baseline (mean) 8.9 8.9 9.0
Change from baseline
(adjusted mean) (95%
CI)
−1.49
(−1.64, −1.34)
−1.23
(−1.38, −1.08)
−1.00
(−1.15, −0.85)
Difference from
dapagliflozin +
metformin (adjusted
mean) (95% CI)
−0.26‡
(−0.47, −0.05)
Difference from
saxagliptin +
metformin (adjusted
mean) (95% CI)
−0.49§
(−0.70, −0.27)
Percent of patients
achieving HbA1c <7% 40.2¶ 21.2¶ 16.5¶
*Analysis of Covariance including all post-baseline data regardless of rescue or treatment discontinuation.
Model estimates calculated using multiple imputation to model washout of the treatment effect using controlarm data for all subjects having missing Week 24 data.
†The number of randomized subjects who took at least one dose of double-blind study medication and had abaseline value for HbA1c.
¶ Not statistically significant based on the prespecified method for controlling type I error.
The adjusted mean change from baseline for body weight at Week 24, using values regardless of rescue ortreatment discontinuation, was -2.0 kg for the 10 mg dapagliflozin and 5 mg saxagliptin plus metformingroup, -2.3 kg for the 10 mg dapagliflozin plus metformin group, and 0 kg for the 5 mg saxagliptin plus
metformin group.
14.2 Add-on Therapy with Saxagliptin in Patients on Dapagliflozin plus MetforminA total of 315 patients with type 2 diabetes participated in this 24-week randomized, double-blind,placebo-controlled trial to eva luate the efficacy and safety of saxagliptin added to dapagliflozin and metformin in patients with a baseline of HbA1c ≥7% to ≤10.5% (NCT01619059). The mean age of thesesubjects was 54.6 years, 1.6% were 75 years or older, and 52.7% were female. The population was 87.9%White, 6.3% Black or African American, 4.1% Asian, and 1.6% Other race. At baseline the populationhad diabetes for an average of 7.7 years and a mean HbA1c of 7.9%. The mean eGFR at baseline was93.4 mL/min/1.73 m2.
Patients were required to be on a stable dose of metformin (≥1500 mg per day) forat least 8 weeks prior to enrollment. Eligible subjects who completed the screening period entered thelead-in treatment period, which included 16 weeks of open-label metformin and 10 mg dapagliflozintreatment. Following the lead-in period, eligible patients were randomized to 5 mg saxagliptin (N=153) orplacebo (N=162).
The group treated with add-on saxagliptin had statistically significant greater reductions in HbA1c frombaseline versus the group treated with placebo (see Table 13).
Table 13: HbA1c Change from Baseline at Week 24 in a Placebo-Controlled Trial of
Saxagliptin as Add-on to Dapagliflozin and Metformin*
Efficacy Parameter
5 mg Saxagliptin
(N=153)†
Placebo
(N=162)†
In combination with Dapagliflozin and
Metform |
