ter initiation of rescue medication. For those patients who did not receive rescue medication and had values measured at 26 weeks, the mean changes from baseline for HbA1c were -0.2%, -0.8%, and -0.9% for placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively. † Intent-to-treat analysis using ANCOVA adjusted for baseline value, prior antihyperglycemic medication and baseline eGFR. ‡ p<0.001 compared to placebo.
HbA1c (%) N = 152 N = 155 N = 152
Baseline (mean) 8.0 8.1 8.0
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, STEGLATRO 5 mg, and STEGLATRO 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, STEGLATRO 5 mg, and STEGLATRO 15 mg groups, respectively. The difference from placebo (95% CI) for STEGLATRO 5 mg was -1.9 kg (-2.6, -1.3) and for STEGLATRO 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, STEGLATRO 5 mg, and STEGLATRO 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, STEGLATRO 5 mg, and STEGLATRO 15 mg groups, respectively. The difference from placebo (95% CI) for STEGLATRO 5 mg was -3.7 mmHg (-6.1, -1.2) and for STEGLATRO 15 mg was -4.3 mmHg (-6.7, -1.9).
Initial Combination Therapy with 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 STEGLATRO 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, STEGLATRO 5 mg or STEGLATRO 15 mg in combination with sitagliptin (100 mg) once daily.
At Week 26, treatment with STEGLATRO 5 mg and 15 mg in combination with sitagliptin at 100 mg daily provided statistically significant reductions in HbA1c compared to placebo. STEGLATRO 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% and greater reductions in FPG compared with placebo.
14.4 Clinical Study of STEGLATRO in Patients with Moderate Renal Impairment and Type 2 Diabetes Mellitus
The efficacy of STEGLATRO was assessed in a multicenter, randomized, double-blind, placebo-controlled study (NCT01986855) of patients with type 2 diabetes mellitus and moderate renal impairment (468 patients with eGFR ≥30 to <60 mL/min/1.73 m2). In this study, 202 patients exposed to STEGLATRO (5 mg or 15 mg) had an eGFR between 45 an
