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| |  Linagliptin Shows Promise in Patients With Poorly Controlled Diabetes, Unsuited to Metformin Treatment: Presented at EASD By Jill Stein STOCKHOLM, Sweden -- September 21, 2010 -- Monotherapy with linagliptin improves glycaemic control in patients with type 2 diabetes in whom metformin therapy is inappropriate because of intolerability or a contraindication, researchers reported here today at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD). Anthony H. Barnett, MD, University of Birmingham and Heart of England NHS Foundation Trust, Birmingham, United Kingdom, and colleagues compared linagliptin 5 mg QD with placebo in 227 hyperglycaemic patients with type 2 patients who were treatment-naive or pre-treated with 1 oral anti-diabetic agent after a 6-week washout period. The 18-week, randomised, double-blind study was followed by a 34-week double-blind extension phase in which placebo-treated patients were switched to glimepiride. Because metformin is not tolerated at high doses in all patients, alternative therapies are needed, as are for patients who have contraindications to metformin, the authors noted in their poster presentation. The primary endpoint was the change in haemoglobin A1C (Hb A1C) from baseline to after 18 weeks of treatment. In the study, metformin was inappropriate in most patients because they were not able to tolerate gastrointestinal adverse events. An interim analysis conducted after all patients had completed 18 weeks of their assigned treatment showed that the adjusted mean difference between linagliptin and placebo was 0.57% (P < .0001) in favour of linagliptin for change in Hb A1C. Significant differences between linagliptin- and placebo-treated patients were observed by week 6 and were sustained through the 18th week. More patients achieved a reduction in Hb A1C >= 0.5% after 18 weeks in the linagliptin group than in the placebo group (36.1% vs 17.8%; P = .0046). Patients receiving linagliptin treatment were more likely to achieve an Hb A1C >= 7.0% than those receiving placebo (27.9% vs 15.1%, respectively). Overall, the rate of reported adverse events was similar between groups (48.7% of patients in the placebo group and 40.4% of patients in the linagliptin group). There were no reported hypoglycaemic events in the placebo group and 2 reported episodes in the linagliptin group. Both episodes were mild and did not lead to drug discontinuation. There was no weight difference between groups. Funding for this study was provided by Boehringer Ingelheim. [Presentation title: Linagliptin Monotherapy Improves Glycaemic Control in Type 2 Diabetes Patients for Whom Metformin Therapy is Inappropriate. Abstract 823]
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