PMID- 27484756
OWN - NLM
STAT- MEDLINE
DCOM- 20170724
LR  - 20221207
IS  - 1590-3729 (Electronic)
IS  - 0939-4753 (Linking)
VI  - 26
IP  - 10
DP  - 2016 Oct
TI  - Efficacy and safety of linagliptin according to patient baseline characteristics: 
      A pooled analysis of three phase 3 trials.
PG  - 886-92
LID - S0939-4753(16)30107-7 [pii]
LID - 10.1016/j.numecd.2016.06.015 [doi]
AB  - BACKGROUND AND AIMS: We aimed to determine if patient baseline characteristics 
      affect responses to linagliptin and identify relevant predictors of glycated 
      hemoglobin (HbA1c) reduction in patients with type 2 diabetes mellitus (T2DM). 
      METHODS AND RESULTS: Data were pooled from three 24-week, placebo-controlled 
      trials of similar design (linagliptin, n = 1651; placebo, n = 607). Patients were 
      categorized according to baseline characteristics: age, T2DM duration, gender, 
      body mass index (BMI), Homeostasis Model Assessment of Insulin Resistance 
      (HOMA-IR), and metabolic syndrome (MetS). Changes from baseline in HbA1c after 24 
      weeks were assessed with analysis of covariance (ANCOVA). The proportion of 
      patients with baseline HbA1c >7% achieving HbA1c of </=7% at week 24 were 
      evaluated. Independent predictors of HbA1c response with linagliptin were 
      analyzed in a multivariate analysis with ANCOVA. Linagliptin treatment led to 
      significant mean (SE) placebo-corrected reductions from baseline in HbA1c across 
      all subgroups (-0.42% [+/-0.11] to -0.79% [0.08]; all p < 0.001). Within subgroups, 
      HbA1c reduction was more pronounced in patients without MetS (-0.74% [0.06]; 
      treatment interaction p = 0.0489). The proportion of patients with baseline HbA1c 
      >7% achieving a target HbA1c </=7% was greater with linagliptin versus placebo 
      (30.2% vs 11.5%; odds ratio 3.82; 95% CI 2.82 to 5.17; p < 0.001). 
      Characteristics significantly predicting HbA1c reductions after 24 weeks were 
      fasting plasma glucose and race (both p < 0.05). CONCLUSION: This post-hoc 
      analysis supports that linagliptin achieved clinically meaningful improvements in 
      hyperglycemia in patients with diverse clinical characteristics. These 
      improvements were more pronounced in patients without MetS.
CI  - Copyright (c) 2016 The Italian Society of Diabetology, the Italian Society for the 
      Study of Atherosclerosis, the Italian Society of Human Nutrition, and the 
      Department of Clinical Medicine and Surgery, Federico II University. Published by 
      Elsevier B.V. All rights reserved.
FAU - Del Prato, S
AU  - Del Prato S
AD  - University of Pisa, Pisa, Italy. Electronic address: 
      stefano.delprato@med.unipi.it.
FAU - Patel, S
AU  - Patel S
AD  - Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.
FAU - Crowe, S
AU  - Crowe S
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - von Eynatten, M
AU  - von Eynatten M
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT00621140
SI  - ClinicalTrials.gov/NCT00601250
SI  - ClinicalTrials.gov/NCT00602472
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160701
PL  - Netherlands
TA  - Nutr Metab Cardiovasc Dis
JT  - Nutrition, metabolism, and cardiovascular diseases : NMCD
JID - 9111474
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - EC 3.4.14.5 (DPP4 protein, human)
RN  - EC 3.4.14.5 (Dipeptidyl Peptidase 4)
SB  - IM
MH  - Aged
MH  - Biomarkers/blood
MH  - Blood Glucose/*drug effects/metabolism
MH  - Clinical Trials, Phase III as Topic
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy
MH  - Dipeptidyl Peptidase 4/*metabolism
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Linagliptin/adverse effects/*therapeutic use
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Odds Ratio
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Asian
OT  - Body mass index
OT  - DPP-4 inhibitor
OT  - Fasting plasma glucose
OT  - Linagliptin
OT  - Metabolic syndrome
OT  - Race
OT  - Type 2 diabetes
EDAT- 2016/08/04 06:00
MHDA- 2017/07/25 06:00
CRDT- 2016/08/04 06:00
PHST- 2015/04/01 00:00 [received]
PHST- 2016/06/03 00:00 [revised]
PHST- 2016/06/24 00:00 [accepted]
PHST- 2016/08/04 06:00 [entrez]
PHST- 2016/08/04 06:00 [pubmed]
PHST- 2017/07/25 06:00 [medline]
AID - S0939-4753(16)30107-7 [pii]
AID - 10.1016/j.numecd.2016.06.015 [doi]
PST - ppublish
SO  - Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 
      10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.