Long-term safety of linagliptin monotherapy in Japanese patients with type 2 diabetes.

Abstract

AIMS:

In a phase III study conducted among Japanese patients with type 2 diabetes mellitus (T2DM), linagliptin 5 and 10 mg showed clinically meaningful improvements in glycaemic parameters after 12 and 26 weeks compared with placebo and voglibose, respectively. This extension study assessed long-term tolerability of linagliptin over 52 weeks.

METHODS:

Japanese patients with T2DM who completed either phase of a 12-week/26-week study comparing linagliptin monotherapy with placebo or voglibose were eligible to enrol. In the extension study, the comparator groups switched to linagliptin 5 or 10 mg, while the linagliptin groups maintained dosage.

RESULTS:

In all, 540 patients received at least one dose of linagliptin 5 or 10 mg and 494 completed the extension. Long-term treatment with linagliptin was well tolerated; adverse events (AEs) of special interest and serious AEs occurred in small percentages of patients. Drug-related AEs occurred in 10.2 and 10.6% of patients in the linagliptin 5- and 10-mg groups, respectively, and discontinuations due to drug-related AEs occurred in 1.1 and 0.7%, respectively. Only one (0.4%) patient in each dose group experienced investigator-defined hypoglycaemia during the treatment period (both events were non-severe). Body weight was not clinically altered in either group. The glycated haemoglobin A1c profiles over time were similar with linagliptin 5 and 10 mg.

CONCLUSIONS:

These findings provide evidence for the safety and tolerability of oral linagliptin at either 5 or 10 mg for up to 52 weeks for the treatment of Japanese patients with T2DM, without clinically relevant increase in the risk of hypoglycaemia or weight gain.

• Authors: E Araki, R Kawamori, N Inagaki, H Watada, N Hayashi, Y Horie, A Sarashina, S Thiemann, M von Eynatten, K Dugi, H-J Woerle
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 15 Issue 4 Pg. 364-71 (Apr 2013) ISSN: 1463-1326 [Electronic] England
• PMID: 23163910 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2012 Blackwell Publishing Ltd.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Purines
• Quinazolines
• hemoglobin A1c protein, human
• Linagliptin
• Inositol
• voglibose

Topics

• Adult
• Aged
• Aged, 80 and over
• Asian People
• Blood Glucose (drug effects, metabolism)
• Body Mass Index
• Body Weight
• Diabetes Mellitus, Type 2 (blood, drug therapy, ethnology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Glycated Hemoglobin (drug effects, metabolism)
• Humans
• Hypoglycemic Agents (therapeutic use)
• Inositol (analogs & derivatives, therapeutic use)
• Linagliptin
• Male
• Middle Aged
• Purines (therapeutic use)
• Quinazolines (therapeutic use)
• Time Factors