Dou J, et al. - A combination of saxagliptin with metformin was tested for efficacy and safety in pharmacotherapy-naïve Chinese patients with type 2 diabetes mellitus and inadequate glycemic control (HbA_1c 8.0–12.0%) when administered for over 24 weeks. This combo (saxagliptin + metformin) afforded significant improvement in glycemic control, compared with either monotherapy and was well tolerated.

Methods

• Researchers performed a multicenter, double-blind, active-controlled study (The START study: NCT02273050), wherein, they randomized (1:1:1) patients to saxagliptin 5 mg plus metformin, saxagliptin 5 mg plus placebo, or metformin plus placebo.
• Saxagliptin was taken once daily; metformin was taken once/twice daily and was titrated from 500 mg to a maximum of 2000 mg/day over 8 weeks.
• Change in HbA_1c from baseline to week 24 was the primary end point.

Results

• This study analyzed data from 630 patients (66.5% men; mean age 50.1 years; mean body mass index, 26.6 kg/m²; mean HbA_1c 9.4%; mean diabetes duration, 0.81 years).
• Saxagliptin plus metformin (-3.0%), compared with saxagliptin plus placebo (-2.1%; P < 0.001) or metformin plus placebo (-2.8%; P = 0.034), provided greater mean HbA_1c reduction.
• Researchers observed that changes in mean fasting plasma glucose, 120-min postprandial glucose, and 180-min postprandial glucose area under curve were greater, and treatment with saxagliptin plus metformin versus with either monotherapy yielded a therapeutic glycemic response in more patients.
• Data also reported infrequent (<2%) hypoglycemic events.
• Among groups, the reported incidence of adverse events was similar; upper respiratory tract infection and diarrhea were most common.