Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study

利格列汀 二甲双胍 安慰剂 医学 2型糖尿病 内科学 糖尿病 随机对照试验 胃肠病学 二肽基肽酶-4抑制剂 内分泌学 病理 替代医学
作者
Marja‐Riitta Taskinen,Julio Rosenstock,Ilkka Tamminen,R. Kubiak,S. Patel,Klaus A. Dugi,Hans J. Woerle
出处
期刊:Diabetes, Obesity and Metabolism [Wiley]
卷期号:13 (1): 65-74 被引量:296
标识
DOI:10.1111/j.1463-1326.2010.01326.x
摘要

Aim: To evaluate the efficacy and safety of the potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin administered as add-on therapy to metformin in patients with type 2 diabetes with inadequate glycaemic control. Methods: This 24-week, randomized, placebo-controlled, double-blind, parallel-group study was carried out in 82 centres in 10 countries. Patients with HbA1c levels of 7.0–10.0% on metformin and a maximum of one additional antidiabetes medication, which was discontinued at screening, continued on metformin ≥1500 mg/day for 6 weeks, including a placebo run-in period of 2 weeks, before being randomized to linagliptin 5 mg once daily (n = 524) or placebo (n = 177) add-on. The primary outcome was the change from baseline in HbA1c after 24 weeks of treatment, evaluated with an analysis of covariance (ANCOVA). Results: Mean baseline HbA1c and fasting plasma glucose (FPG) were 8.1% and 9.4 mmol/l, respectively. Linagliptin showed significant reductions vs. placebo in adjusted mean changes from baseline of HbA1c (−0.49 vs. 0.15%), FPG (−0.59 vs. 0.58 mmol/l) and 2hPPG (−2.7 vs. 1.0 mmol/l); all p < 0.0001. Hypoglycaemia was rare, occurring in three patients (0.6%) treated with linagliptin and five patients (2.8%) in the placebo group. Body weight did not change significantly from baseline in both groups (−0.5 kg placebo, −0.4 kg linagliptin). Conclusions: The addition of linagliptin 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin resulted in a significant and clinically meaningful improvement in glycaemic control without weight gain or increased risk of hypoglycaemia.
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