bsp;
Change from baseline (LS mean†) -0.2 -0.7 -0.8
Difference from placebo (LS mean†, 95% CI) -0.5‡ (-0.7, -0.3) -0.6‡ (-0.8, -0.4)
Patients [N (%)] with HbA1c <7% 31 (20.2) 54 (34.6) 64 (42.3)
FPG (mg/dL) N = 152 N = 156 N = 152
Baseline (mean) 169.6 167.7 171.7
Change from baseline (LS mean†) -6.5 -25.7 -32.1
Difference from placebo (LS mean†, 95% CI) -19.2‡ (-26.8, -11.6) -25.6‡ (-33.2, -18.0)
The mean baseline body weight was 86.5 kg, 87.6 kg, and 86.6 kg in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The mean changes from baseline to Week 26 were -1.0 kg, -3.0 kg, and -2.8 kg in the placebo, ertugliflozin 5 mg and ertugliflozin 15 mg groups, respectively. The difference from placebo (95% CI) for ertugliflozin 5 mg was -1.9 kg (-2.6, -1.3) and for ertugliflozin 15 mg was -1.8 kg (-2.4, -1.2).
The mean baseline systolic blood pressure was 130.2 mmHg, 132.1 mmHg, and 131.6 mmHg in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The mean changes from baseline to Week 26 were -0.2 mmHg, -3.8 mmHg, and -4.5 mmHg in the placebo, ertugliflozin 5 mg and ertugliflozin 15 mg groups, respectively. The difference from placebo (95% CI) for ertugliflozin 5 mg was -3.7 mmHg (-6.1, -1.2) and for ertugliflozin 15 mg was -4.3 mmHg (-6.7, -1.9).
14.4 Initial Combination Therapy of Ertugliflozin and Sitagliptin
A total of 291 patients with type 2 diabetes mellitus inadequately controlled (HbA1c between 8% and 10.5%) on diet and exercise participated in a randomized, double-blind, multi-center, placebo-controlled 26-week study (NCT02226003) to eva luate the efficacy and safety of ertugliflozin in combination with sitagliptin. These patients, who were not receiving any background antihyperglycemic treatment for ≥8 weeks, entered a 2-week, single-blind, placebo run-in period and were randomized to placebo, ertugliflozin 5 mg, ertugliflozin 15 mg in combination with sitagliptin (100 mg), once daily.
At Week 26, treatment with ertugliflozin 5 mg and 15 mg in combination with sitagliptin at 100 mg daily provided statistically significant reductions in HbA1c compared to placebo. Ertugliflozin 5 mg and 15 mg in combination with sitagliptin at 100 mg daily also resulted in a higher proportion of patients achieving an HbA1c <7% compared with placebo (see Table 8).
Table 8: Results at Week 26 from an Initial Combination Therapy Study of Ertugliflozin and Sitagliptin*
Placebo
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin 15 mg + Sitagliptin 100 mg
* N includes all randomized and treated patients with a baseline measurement of the outcome variable. At Week 26 the primary HbA1c endpoint was missing for 22%, 7% and 10% of patients and during the trial rescue medication was initiated by 32%, 6%, and 0% of patients randomized to placebo, ertugliflozin 5 mg and ertugliflozin 15 mg, respectively. Missing Week 26 measurements were imputed using multiple imputation with a mean equal to the baseline value of the patient. Results included measurements collected after initiation of rescue medication. For those subjects who did not receive rescue medication and had values measured at 26 weeks, the mean change from baseline for HbA1c was -0.8%, -1.7%, -1.7% for placebo, ertugliflozi
