title: Long-term safety of linagliptin monotherapy in Japanese patients with type 2 diabetes.
abstract: OBJECTIVE
  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.affiliation: Department of Metabolic Medicine, Kumamoto University Graduate School of Medicine, Kumamoto, Japan.
authors.forename: E
authors.initials: E
authors.lastname: Araki
authors.forename: R
authors.initials: R
authors.lastname: Kawamori
authors.forename: N
authors.initials: N
authors.lastname: Inagaki
authors.forename: H
authors.initials: H
authors.lastname: Watada
authors.forename: N
authors.initials: N
authors.lastname: Hayashi
authors.forename: Y
authors.initials: Y
authors.lastname: Horie
authors.forename: A
authors.initials: A
authors.lastname: Sarashina
authors.forename: S
authors.initials: S
authors.lastname: Thiemann
authors.forename: M
authors.initials: M
authors.lastname: von Eynatten
authors.forename: K
authors.initials: K
authors.lastname: Dugi
authors.forename: H-J
authors.initials: HJ
authors.lastname: Woerle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D015992:Body Mass Index; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007294:Inositol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069476:Linagliptin; D008297:Male; D008875:Middle Aged; D011687:Purines / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007294:Inositol; D000069476:Linagliptin; D011687:Purines; D011799:Quinazolines; C517652:hemoglobin A1c protein, human; C102817:voglibose