The mean baseline body weight was 86.8 kg, 87.9 kg, and 85.6 kg in the glimepiride, STEGLATRO 5 mg, and STEGLATRO 15 mg groups, respectively. The mean changes from baseline to Week 52 were 0.6 kg, -2.6 kg, and -3.0 kg in the glimepiride, STEGLATRO 5 mg, and STEGLATRO 15 mg groups, respectively. The difference from glimepiride (95% CI) for STEGLATRO 5 mg was -3.2 kg (-3.7, -2.7) and for STEGLATRO 15 mg was -3.6 kg (-4.1, -3.1).

In Combination with Sitagliptin versus STEGLATRO Alone and Sitagliptin Alone, as Add-on to Metformin 

 

A total of 1,233 patients with type 2 diabetes mellitus with inadequate glycemic control (HbA1c between 7.5% and 11%) on metformin monotherapy (≥1,500 mg/day for ≥8 weeks) participated in a randomized, double-blind, 26-week, active controlled study (NCT NCT02099110) to eva luate the efficacy and safety of STEGLATRO 5 mg or 15 mg in combination with sitagliptin 100 mg compared to the individual components. Patients were randomized to one of five treatment arms: STEGLATRO 5 mg, STEGLATRO 15 mg, sitagliptin 100 mg, STEGLATRO 5 mg + sitagliptin 100 mg, or STEGLATRO 15 mg + sitagliptin 100 mg.

 

At Week 26, STEGLATRO 5 mg or 15 mg + sitagliptin 100 mg provided statistically significantly greater reductions in HbA1c compared to STEGLATRO (5 mg or 15 mg) alone or sitagliptin 100 mg alone. The mean change from baseline in HbA1c was -1.4% for STEGLATRO 5 mg or 15 mg + sitagliptin 100 mg versus -1.0%, for STEGLATRO 5 mg, STEGLATRO 15 mg, or sitagliptin 100 mg, respectively. More patients receiving STEGLATRO 5 mg or 15 mg + sitagliptin 100 mg achieved an HbA1c <7% (53.3% and 50.9%, for STEGLATRO 5 mg or 15 mg, respectively, + sitagliptin 100 mg) compared to the individual components (29.3%, 33.7%, and 38.5% for STEGLATRO 5 mg, STEGLATRO 15 mg, or sitagliptin 100 mg, respectively).

 

Add-on Combination Therapy with Metformin and Sitagliptin 

 

A total of 463 patients with type 2 diabetes mellitus inadequately controlled (HbA1c between 7% and 10.5%) on metformin (≥1,500 mg/day for ≥8 weeks) and sitagliptin 100 mg once daily participated in a randomized, double-blind, multi-center, 26-week, placebo-controlled study (NCT02036515) to eva luate the efficacy and safety of STEGLATRO. Patients entered a 2-week, single-blind, placebo run-in period and were randomized to placebo, STEGLATRO 5 mg, or STEGLATRO 15 mg.

 

At Week 26, treatment with STEGLATRO at 5 mg or 15 mg daily provided statistically significant reductions in HbA1c. STEGLATRO also resulted in a higher proportion of patients achieving an HbA1c <7% compared to placebo (see Table 7).

 

 

Table 7: Results at Week 26 from an Add-on Study of STEGLATRO in Combination with Metformin and Sitagliptin in Patients with Type 2 Diabetes Mellitus* 

 

Placebo

 

STEGLATRO 5 mg

 

STEGLATRO 15 mg