Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes

摘要

Aims: To assess efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in combination therapy with metformin (≥ 1500 mg/day) and pioglitazone (≥ 30 mg/day) in patients with type 2 diabetes (T2DM) with inadequate glycemic control (hemoglobin A1c [HbA1c] ≥ 7.5% and ≤ 11%). Methods: This placebo-controlled, double-blind study included 313 patients, mean baseline HbA1c = 8.7%, who were randomized to receive sitagliptin 100 mg/day or placebo for 26 weeks. Results: The addition of sitagliptin led to significant (P .001) mean changes from baseline relative to placebo in HbA1c (- 0.7%), fasting plasma glucose (- 1.0 mmol/L), and 2-h post-meal glucose (- 2.2 mmol/L). In patients with baseline HbA1c ≥ 9.0%, mean changes from baseline in HbA 1c were - 1.6% and - 0.8% for the sitagliptin and placebo groups, respectively (between-group difference -0.8%; P .001). The incidences of reported adverse events were generally similar between the treatment groups. Incidences of symptomatic hypoglycemia were 7/157 [4.5%] and 6/156 [3.8%] in the sitagliptin and placebo groups, respectively (P =.786). Two patients, both in the placebo group, experienced an episode of hypoglycemia that required non-medical assistance. Conclusions: In this 26-week study, addition of sitagliptin to combination therapy with metformin and pioglitazone improved glycemic control and was generally well tolerated.