Sitagliptin effective, well-tolerated in Japanese Type 2 diabetics
MedWire News: Once-daily sitagliptin offers superior efficacy and tolerability compared with thrice-daily voglibose in Japanese patients with Type 2 diabetes, clinical trial results indicate.
In a randomized, controlled, 12-week trial, patients assigned to sitagliptin experienced greater reductions in glycated hemoglobin (HbA1c), fewer gastrointestinal adverse events, and a similar rate of hypoglycemia versus patients assigned to voglibose.
The trial was undertaken by Juan Arjona Ferreira (Merck & Co, Inc, Rahway, New Jersey, USA) and team to test the hypothesis that sitagliptin, a newly approved highly selective dipeptidyl peptidase-4 inhibitor, is non-inferior to the α-glucosidase inhibitor, voglibose.
In all, 319 Japanese patients with Type 2 diabetes were randomly assigned to 12 weeks’ treatment with either sitagliptin 50.0 mg once daily or voglibose 0.2 mg thrice-daily.
The primary analysis revealed that HbA1c decreased between baseline and week 12 by 0.7% in the sitagliptin group versus 0.3% in the voglibose group, thereby achieving statistical criteria for both non-inferiority and superiority.
Sitagliptin was also superior to voglibose on other key efficacy endpoints, such as the change in 2-hour postprandial glucose (–2.8 vs –1.8 mmol/l) and change in fasting plasma glucose (–1.1 vs –0.5 mmol/l).
In terms of safety, rates of clinical, drug-related, and gastrointestinal adverse events were all significantly lower with sitagliptin versus voglibose (48.5% vs 64.7%, 10.4% vs 26.3%, and 18.4% vs 34.6%, respectively).
Furthermore, rates of hypoglycemia, discontinuations, and serious adverse events were similarly low in the two groups. All hypoglycemic events were mild or moderate and none required medical intervention or resulted in discontinuation. Both treatment groups had a small but significant reduction in body weight.
Writing in the journal Diabetes, Obesity, and Metabolism, Ferreira et al say that the study supports the efficacy and tolerability of sitagliptin therapy in the Japanese diabetic population.
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By Joanna Lyford