The oral DPP‐4 inhibitor linagliptin significantly lowers HbA1c after 4 weeks of treatment in patients with type 2 diabetes mellitus

利格列汀 医学 二肽基肽酶-4抑制剂 内科学 2型糖尿病 糖尿病 二肽基肽酶-4 2型糖尿病 药理学 内分泌学
作者
Thomas Först,B. Uhlig‐Laske,Arne Ring,Armin Ritzhaupt,Ulrike Graefe‐Mody,Klaus A. Dugi
出处
期刊:Diabetes, Obesity and Metabolism [Wiley]
卷期号:13 (6): 542-550 被引量:54
标识
DOI:10.1111/j.1463-1326.2011.01386.x
摘要

Aim: To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of linagliptin in patients with type 2 diabetes mellitus (T2DM). Methods: After screening and a 14‐day washout, subjects received linagliptin 2.5, 5 or 10 mg or placebo once‐daily for 28 days in this randomized, double‐blind, parallel, placebo‐controlled within‐dose groups study. Results: Seventy‐seven patients entered the study (linagliptin: 61; placebo: 16). Four patients withdrew prematurely. There was little evidence of linagliptin accumulation. Exposure, maximum and trough plasma concentrations of linagliptin increased less than dose‐proportionally. Rapid and sustained inhibition of dipeptidyl peptidase‐4 reached 91–93% across linagliptin doses at steady state. At the end of the 24‐h dosing interval, inhibition was still high (82–90%). There were marked increases in plasma glucagon‐like peptide‐1 after 28 days of dosing. Compared to placebo, all linagliptin doses resulted in statistically significant decreases of the area under the glucose curve following a meal tolerance test on day 29, that is, 24 h after the last study drug intake. After 28 days of treatment with linagliptin the placebo‐corrected mean change in haemoglobin A1c (HbA1c) (median baseline 7.0%) was −0.31% (2.5‐mg dose), −0.37% (5‐mg dose) and −0.28% (10‐mg dose). The frequency of adverse events was similar for linagliptin (31%) and placebo (34%). There were no notable safety concerns. Conclusions: Linagliptin administration led to attenuation of postprandial glucose excursions and, despite a low HbA1c at baseline, statistically significant reductions in HbA1c after only 4 weeks of treatment. Linagliptin had a safety and tolerability profile similar to placebo in T2DM patients.

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