Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled Type 2 diabetes T. Forst et al. Linagliptin added to metformin in Type 2 diabetes.

Autor:	Forst, T., Uhlig-Laske, B., Ring, A., Graefe-Mody, U., Friedrich, C., Herbach, K., Woerle, H.-J., Dugi, K. A.
Předmět:	ANALYSIS of covariance ANALYSIS of variance COMBINATION drug therapy STATISTICAL correlation DRUG resistance ENZYME inhibitors GLYCOSYLATED hemoglobin HYPOGLYCEMIC agents MEDICAL cooperation TYPE 2 diabetes HEALTH outcome assessment REGRESSION analysis RESEARCH STATISTICAL sampling TREATMENT effectiveness BLIND experiment METFORMIN BLOOD DRUG administration DRUG dosage DRUG side effects PHARMACOKINETICS DRUG therapy
Zdroj:	Diabetic Medicine; Dec2010, Vol. 27 Issue 12, p1409-1419, 11p, 1 Diagram, 4 Charts, 3 Graphs
Abstrakt:	Aims The efficacy and safety of the dipeptidyl peptidase-4 inhibitor, linagliptin, added to ongoing metformin therapy, were assessed in patients with Type 2 diabeteswho had inadequate glycaemic control (HbA1c⩾ 7.5 to ⩽ 10%; ⩾58.5 to ⩽85.8mmol / mol) with metformin alone. Methods Patients (n = 333)were randomized to receive double-blind linagliptin (1,5 or10 mg oncedaily)or placeboor openlabel glimepiride (1-3 mg once daily). The primary outcome measure was the change from baseline in HbA1c at week 12 in patients receiving combination therapy compared with metformin alone. Results Twelve weeks of treatment resulted in a mean (sem) placebo-corrected lowering in HbA1c levels of 0.40% (± 0.14); 4.4 mmol / mol (± 1.5) for 1 mg linagliptin, 0.73% (± 0.14); 8.0 mmol/ mol (± 1.5) for 5 mg, and 0.67% (± 0.14); 7.3 mmol / mol (± 1.5) for 10 mg. Differences between linagliptin and placebo were statistically significant for all doses (1 mg, P = 0.01; 5 mg and 10 mg, P < 0.0001). The change in mean (sem) placebo-corrected HbA1c from baseline was )0.90% (± 0.13);)9.8mmol / mol (± 1.4) for glimepiride. Adjusted and placebo-correctedmean changes in fasting plasma glucosewere )1.1 mmol/ l for linagliptin 1 mg (P = 0.002), )1.9 mmol / l for 5 mg and )1.6 mmol / l for 10 mg (both P < 0.0001). One hundred and six (43.1%) patients reported adverse events; the incidence was similar across all five groups. There were no hypoglycaemic events for linagliptin or placebo, whereas three patients (5%) receiving glimepiride experienced hypoglycaemia. Conclusions The addition of linagliptin to ongoing metformin treatment in patients with Type 2 diabetes was well tolerated and resulted in significant and clinically relevant improvements in glycaemic control, with 5 mg linagliptin being the most effective dose. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
Externí odkaz:	Zobrazit plný text záznamu Plný text