Linagliptine effectief en goed verdraagzaam i.c.m. metformineNieuws - Sep. 16, 2010
Linagliptin effective and well tolerated in combination with metformin
Linagliptin (Boehringer Ingelheim GmbH) is an effective and well-tolerated addition to metformin treatment for reducing glycated hemoglobin (HbA1c) in patients with Type 2 diabetes, show study findings.
Linagliptin is the latest oral antihyperglycemic drug to be developed in the dipeptidyl peptidase (DPP)-4 inhibitor class and has previously shown promise in early studies.
In this study, the researchers randomly assigned 333 patients with Type 2 diabetes and inadequate glycemic control (HbA1c 7.5-10.0%) to take placebo (n=71), open-label glimepiride 1-3 mg/day (n=65), or linagliptin 1, 5, or 10 mg/day (n= 65, 66, 66, respectively) for 12 weeks.The primary study outcome was reduction in HbA1c at study completion. The participants were aged 21-75 years and had a body mass index (BMI) of 25-40 kg/m2. All of the participants were also taking a standard dose of metformin.
The team reports that, compared with the placebo group, the linagliptin 1, 5, and 10 mg/day groups had significant reductions in HbA1c of 0.40%, 0.73%, and 0.67%, respectively, from baseline. In comparison, glimepiride produced a placebo-adjusted reduction in HbA1c of 0.90% from baseline. In addition, placebo-corrected mean reductions in fasting plasma glucose from baseline were 1.1, 1.9, and 1.6 mmol/l for the linagliptin 1, 5, and 10 mg/day groups, respectively.
Overall, 43.1% of the participants reported adverse events, but incidence was similar across all five groups. The most commonly reported events were nasopharyngitis, diarrhea, and nausea.Hypoglycemia was experienced by 5% of the patients taking glimepiride, but by none taking linagliptin or placebo.
"In this study, linagliptin as add-on to metformin resulted in a statistically significant and, more importantly, clinically relevant improvement in glycemic control in patients with Type 2 diabetes, without causing hypoglycemia," write the researchers in the journal Diabetic Medicine.
"A possible limitation of this study was the relatively short study duration and, thus, conclusions about longer-term efficacy and safety of linagliptin plus metformin must await the results of long-term trials that are currently ongoing," they add.