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| |  Sitagliptin Plus Metformin Shows Promise for Glycaemic Control, Reduced GI Side Effects: Presented at EASD By Bruce Sylvester VIENNA, Austria -- October 3, 2009 -- Patients with type 2 diabetes receiving initial therapy with the investigational combination sitagliptin/metformin achieve superior glycaemic improvements, more frequent achievement of glycosylated haemoglobin (Hb A1C) goals, and significantly lower incidences of gastrointestinal effects, compared with patients treated with metformin monotherapy. “Key findings that we did not expect to see were significant reductions in the gastrointestinal side effects of abdominal pain and diarrhoea in the combination therapy group compared with metformin monotherapy,” said Debora Williams-Herman MD, Merck Laboratories, Rahway, New Jersey, on October 1 here at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD). The multicentre, double-blind study evaluated the efficacy and safety of initial therapy with sitagliptin plus metformin compared with metformin alone in treatment-naïve patients with type 2 diabetes. A total of 1,250 patients were randomised in a 1:1 ratio to receive sitagliptin 50 mg plus metformin 500 mg BID or metformin 500 mg BID for 18 weeks. Metformin titration was allowed over 4 weeks to reach 1,000 mg in both groups. Hb A1C reductions from baseline were -2.4% (95% confidence interval [CI], -2.5 to -2.2) for sitagliptin/metformin and -1.8% (95% CI, -1.9 to -1.6) for metformin monotherapy, with a statistically significant between-group difference of -0.6% favouring the combination treatment group (P < .001). In addition, significantly more patients in the sitagliptin/metformin group achieved an Hb A1C goal of <7% compared with patients treated with metformin alone (49% vs 34%; P < .001). Reductions in fasting plasma glucose were significantly greater with the combination therapy (-69.5 mg/dL) than with monotherapy (-53.5 mg/dL; P < .001). Incidences of hypoglycaemia were low and not significantly different between the 2 groups (2.1% for sitagliptin/metformin vs 1.8% for metformin; P = .686). Abdominal pain was observed in 1.1% of patients in the combination therapy group and in 3.8% of patients in the monotherapy group (P = .002). Diarrhoea was observed in 12.0% and 16.8% of patients, respectively (P = .015). Funding for this study was provided by Merck. [Presentation title: Initial Therapy With the Fixed-Dose Combination (FDC) of Sitagliptin and Metformin (JANUMET) in Patients With Type 2 Diabetes Mellitus Provides Superior Glycaemic Control and HbA1c Goal Attainment With Lower Rates of Abdominal Pain and Diarrhea vs Metformin Alone. Abstract 751]
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