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| |  Initial Therapy With Sitagliptin/Pioglitazone for Type 2 Diabetes Shows Significant Benefits Over Pioglitazone Alone: Presented at EASD By Bruce Sylvester VIENNA, Austria -- October 5, 2009 -- Compared with initial pioglitazone monotherapy, treatment-naïve patients with type 2 diabetes receiving initial treatment with sitagliptin plus pioglitazone achieve substantially improved glycaemic control, researchers stated here at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD). “In a group of patients with moderately high haemoglobin [Hb] A1C who had not received prior antiglycaemic treatment, we saw a strong decrease in Hb A1C from baseline with initial combination therapy, a strong decrease in fasting plasma glucose,” said Helmut Steinberg, MD, Merck Research Laboratories, Rahway, New Jersey, on October 1. “Sixty percent of the combination therapy patients achieved an [Hb] A1C of less than 7% and no increase in adverse events.” Following a 2-week single-blind placebo run-in phase, researchers randomised 520 patients with a mean baseline Hb A1C of 9.5% to sitagliptin 100 mg once daily plus pioglitazone 30 mg QD, or to pioglitazone 30 mg QD for 24 weeks. Patients using sitagliptin/pioglitazone achieved a reduction from baseline in Hb A1C of 2.4% compared with -1.5% for patients receiving pioglitazone monotherapy. The between-group difference for combination versus monotherapy was statistically significant at -0.9% (P < .001). The researchers noted a greater Hb A1C reduction among patients with a baseline Hb A1C >=10%, with a change from baseline with sitagliptin/pioglitazone of -3.0% versus -2.1% with pioglitazone alone. There were significantly more patients in the combination group who reached an Hb A1C of <7% at week 24 compared with the monotherapy group (60% vs 28%; P < .001). There was also a significant difference between the groups in the reduction of fasting plasma glucose, which fell by -63.0 mg/dL in the combination group compared with -40.2 mg/dL with monotherapy, with a between-group difference of -22.8 mg/dL (P < .001). In addition, 2-hour post-meal glucose fell by -113.6 mg/dL with sitagliptin-plus-pioglitazone compared to -68.9 mg/dL with pioglitazone, showing a significant between-group difference of -44.7 mg/dL (P < .001). The combination therapy was generally well tolerated compared with monotherapy, with similar incidences of hypoglycaemia (1.1% vs 0.8%), gastrointestinal adverse events (5.7% vs 6.9%), and oedema (2.7% vs 3.5%). Funding for this study was provided by Merck. [Presentation title: Initial Combination Therapy With Sitagliptin and Pioglitazone Improves Glycaemic Control and Measures of Beta Cell Function Compared With Pioglitazone Alone in Patients With Type 2 Diabetes. Abstract 747]
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