PMID- 25629790
OWN - NLM
STAT- MEDLINE
DCOM- 20151106
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 3
DP  - 2015 Mar
TI  - Linagliptin improves glycemic control after 1 year as add-on therapy to basal 
      insulin in Asian patients with type 2 diabetes mellitus.
PG  - 503-12
LID - 10.1185/03007995.2015.1010638 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and long-term safety of linagliptin added to 
      basal insulin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately 
      controlled by basal insulin with/without oral agents. RESEARCH DESIGN AND 
      METHODS: This was a post hoc analysis of Asian patients from a global >/=52 week 
      study in which patients on basal insulin were randomized (1:1) to double-blind 
      treatment with linagliptin 5 mg once daily or placebo (NCT00954447). Basal 
      insulin dose remained stable for 24 weeks, after which adjustments could be made 
      according to the investigator's discretion to improve glycemic control. The 
      primary endpoint was the mean change in glycated hemoglobin (HbA1c) from baseline 
      to 24 weeks. RESULTS: Data were available for 154 Asian patients (80 linagliptin, 
      74 placebo). Baseline HbA1c (standard deviation [SD]) was 8.6 (0.9)% (70 [10] 
      mmol/mol). The placebo-corrected mean change (standard error [SE]) in HbA1c from 
      baseline was -0.9 (0.1)% (-10 [1] mmol/mol) (95% confidence interval [CI]: -1.2, 
      -0.7; p<0.0001) at Week 24 and -0.9 (0.1)% (-10 [1] mmol/mol) (95% CI: -1.1, 
      -0.6; p<0.0001) at Week 52. The frequency of adverse events (linagliptin 81.3%, 
      placebo 91.9%) and hypoglycemia (Week 24: linagliptin 25.0%, placebo 25.7%; 
      treatment end: linagliptin 28.8%, placebo 35.1%) was similar between groups. By 
      Week 52, changes (SE) in mean body weight were similar in both groups 
      (linagliptin -0.67 [0.26] kg, placebo -0.38 [0.25] kg). CONCLUSIONS: This study 
      was limited by the post hoc nature of the analysis and the small number of 
      patients in the subgroup. However, the results suggest that linagliptin 
      significantly improves glycemic control in Asian patients with T2DM inadequately 
      controlled by basal insulin, without increasing the risk for hypoglycemia or 
      weight gain. ClinicalTrials identifier: NCT00954447.
FAU - Sheu, Wayne H-H
AU  - Sheu WH
AD  - Taichung Veterans General Hospital , Taichung , Taiwan.
FAU - Park, Sung Woo
AU  - Park SW
FAU - Gong, Yan
AU  - Gong Y
FAU - Pinnetti, Sabine
AU  - Pinnetti S
FAU - Bhattacharya, Sudipta
AU  - Bhattacharya S
FAU - Patel, Sanjay
AU  - Patel S
FAU - Seck, Thomas
AU  - Seck T
FAU - Woerle, Hans-Juergen
AU  - Woerle HJ
LA  - eng
SI  - ClinicalTrials.gov/NCT00954447
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150213
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 3X29ZEJ4R2 (Linagliptin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asian People/statistics & numerical data
MH  - Blood Glucose/analysis
MH  - *Diabetes Mellitus, Type 2/blood/drug therapy/epidemiology
MH  - Double-Blind Method
MH  - Drug Monitoring
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - *Hypoglycemia/chemically induced/prevention & control
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - *Insulin/administration & dosage/adverse effects
MH  - Linagliptin
MH  - Male
MH  - Middle Aged
MH  - *Purines/administration & dosage/adverse effects
MH  - *Quinazolines/administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Weight Gain/drug effects
OTO - NOTNLM
OT  - Asian patients
OT  - Basal insulin
OT  - Linagliptin
OT  - Type 2 diabetes mellitus
EDAT- 2015/01/30 06:00
MHDA- 2015/11/07 06:00
CRDT- 2015/01/29 06:00
PHST- 2015/01/29 06:00 [entrez]
PHST- 2015/01/30 06:00 [pubmed]
PHST- 2015/11/07 06:00 [medline]
AID - 10.1185/03007995.2015.1010638 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Mar;31(3):503-12. doi: 10.1185/03007995.2015.1010638. 
      Epub 2015 Feb 13.