PMID- 23163910
OWN - NLM
STAT- MEDLINE
DCOM- 20130930
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 15
IP  - 4
DP  - 2013 Apr
TI  - Long-term safety of linagliptin monotherapy in Japanese patients with type 2 
      diabetes.
PG  - 364-71
LID - 10.1111/dom.12039 [doi]
AB  - 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.
CI  - (c) 2012 Blackwell Publishing Ltd.
FAU - Araki, E
AU  - Araki E
AD  - Department of Metabolic Medicine, Kumamoto University Graduate School of 
      Medicine, Kumamoto, Japan.
FAU - Kawamori, R
AU  - Kawamori R
FAU - Inagaki, N
AU  - Inagaki N
FAU - Watada, H
AU  - Watada H
FAU - Hayashi, N
AU  - Hayashi N
FAU - Horie, Y
AU  - Horie Y
FAU - Sarashina, A
AU  - Sarashina A
FAU - Thiemann, S
AU  - Thiemann S
FAU - von Eynatten, M
AU  - von Eynatten M
FAU - Dugi, K
AU  - Dugi K
FAU - Woerle, H-J
AU  - Woerle HJ
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20121207
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - 4L6452S749 (Inositol)
RN  - S77P977AG8 (voglibose)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Asian People
MH  - Blood Glucose/drug effects/metabolism
MH  - Body Mass Index
MH  - Body Weight
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/ethnology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glycated Hemoglobin/drug effects/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Inositol/*analogs & derivatives/therapeutic use
MH  - Linagliptin
MH  - Male
MH  - Middle Aged
MH  - Purines/*therapeutic use
MH  - Quinazolines/*therapeutic use
MH  - Time Factors
EDAT- 2012/11/21 06:00
MHDA- 2013/10/01 06:00
CRDT- 2012/11/21 06:00
PHST- 2012/08/06 00:00 [received]
PHST- 2012/09/11 00:00 [revised]
PHST- 2012/11/12 00:00 [accepted]
PHST- 2012/11/21 06:00 [entrez]
PHST- 2012/11/21 06:00 [pubmed]
PHST- 2013/10/01 06:00 [medline]
AID - 10.1111/dom.12039 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2013 Apr;15(4):364-71. doi: 10.1111/dom.12039. Epub 2012 Dec 
      7.