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24-10-2010 | Diabetes | Article

Efficacy of linagliptin plus metformin for treating Type 2 diabetes confirmed


Free abstract

MedWire News: Results from a randomized, placebo controlled study confirm that linagliptin is an effective add-on to metformin for improving glycemic control in patients with Type 2 diabetes.

The novel dipeptidyl peptidase-4 inhibitor linagliptin has previously been shown to be an effective add-on to metformin for treatment of Type 2 diabetics in a small, 12-week study.

For the purposes of this study, Marja-Riitta Taskinen (Helsinki University Central Hospital, Finland) and colleagues recruited 701 participants with Type 2 diabetes and a glycated hemoglobin (HbA1c) level of 7.0-10.0% who were being treated with metformin and a maximum of one other antihyperglycemic drug (discontinued at baseline). The patients were enrolled from 82 centers in 10 countries across the world.

The participants were randomly assigned to take metformin 1500 mg/day or more for a run-in period of 6 weeks and then begin treatment with linagliptin 5 mg/day (n=524) or placebo (n=177) for 24 weeks.

The team found that linagliptin treatment was associated with significant reductions in HbA1c, fasting plasma glucose, and 2-hour post prandial glucose of 0.49%, 0.59 mmol/l, and 2.7 mmol/l, respectively, at 24 weeks compared with baseline. In contrast, placebo treatment was associated with increases of 0.15%, 0.58 mmol/l, and 1.0 mmol/l in these respective values.

Linagliptin was well-tolerated overall and most side effects were mild to moderate, occurring at a similar rate in the placebo and linagliptin groups. Severe adverse events were experienced by 2% and 1% of the linagliptin and placebo groups, respectively.

Rates of hypoglycemia were low and only occurred in 3 linagliptin- and 5 placebo-treated patients. Body weight did not change significantly over the 24 weeks in either the placebo or linagliptin groups.

"This study demonstrates that, for patients inadequately controlled on metformin alone, the addition of linagliptin 5 mg once daily over 24 weeks brings a significant and clinically meaningful improvement in glycemic control, evident in measures of pre and postprandial plasma glucose as well as HbA1c," conclude the authors.

The results of this study are published in the journal Diabetes, Obesity and Metabolism.

MedWire ( is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

By Helen Albert