PMID- 25452864
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141202
LR  - 20181113
IS  - 2052-4897 (Print)
IS  - 2052-4897 (Electronic)
IS  - 2052-4897 (Linking)
VI  - 2
IP  - 1
DP  - 2014
TI  - Efficacy and safety of linagliptin in Hispanic/Latino patients with type 2 
      diabetes mellitus: a pooled analysis from six randomized placebo-controlled phase 
      3 trials.
PG  - e000020
LID - 10.1136/bmjdrc-2014-000020 [doi]
LID - e000020
AB  - OBJECTIVE: The number of individuals diagnosed with type 2 diabetes mellitus is 
      expected to rise disproportionately in Hispanic/Latino populations. We therefore 
      aimed to assess the efficacy and safety of the dipeptidyl peptidase-4 inhibitor 
      linagliptin specifically in Hispanic/Latino patients with type 2 diabetes 
      mellitus. RESEARCH DESIGN AND METHODS: Data from 745 patients who self-identified 
      their ethnicity as Hispanic or Latino were pooled from six randomized, 
      placebo-controlled phase 3 trials. Participants received linagliptin (5 mg/day) 
      or placebo as monotherapy, or in combination with other oral antidiabetes drugs 
      for 18 or 24 weeks. RESULTS: The placebo-adjusted mean change (95% CI) in 
      glycated hemoglobin from baseline (mean 8.2%) was -0.63% (-0.77 to -0.48; 
      p<0.0001) at week 18, and -0.58% (-0.74 to -0.42; p<0.0001) at week 24. The 
      placebo-adjusted mean change (95% CI) in fasting plasma glucose from baseline was 
      -11.7 mg/dL (-19.3 to -4.0; p=0.0028) at week 18 and -14.1 mg/dL (-22.0 to -6.3; 
      p=0.0004) at week 24. Hypoglycemia incidence was 17.4% with linagliptin and 21% 
      with placebo. In patients not receiving concomitant sulfonylurea, the 
      hypoglycemia incidence was 10.1% with linagliptin and 19.4% with placebo. The 
      overall incidence of adverse events (AEs), drug-related AEs, and serious AEs with 
      linagliptin was similar to placebo (AEs 67.6% vs 68.9%; drug-related AEs 15.1% vs 
      18.7%; serious AEs 3.6% vs 3.0%). The mean body weight remained unchanged in both 
      groups. CONCLUSIONS: In Hispanic/Latino patients with inadequately controlled 
      type 2 diabetes mellitus, linagliptin provided clinically meaningful improvements 
      in glycemic control without weight gain or increased risk of hypoglycemia.
FAU - Davidson, Jaime A
AU  - Davidson JA
AD  - The University of Texas Southwestern Medical Center , Dallas, Texas , USA.
FAU - Lajara, Rosemarie
AU  - Lajara R
AD  - Diabetes America-PA President , Plano, Texas , USA.
FAU - Aguilar, Richard B
AU  - Aguilar RB
AD  - Diabetes Nation , Sisters, Oregon , USA.
FAU - Mattheus, Michaela
AU  - Mattheus M
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG , Ingelheim , Germany.
FAU - Woerle, Hans-Juergen
AU  - Woerle HJ
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG , Ingelheim , Germany.
FAU - von Eynatten, Maximilian
AU  - von Eynatten M
AD  - Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield, Connecticut , USA.
LA  - eng
PT  - Journal Article
DEP - 20140416
PL  - England
TA  - BMJ Open Diabetes Res Care
JT  - BMJ open diabetes research & care
JID - 101641391
PMC - PMC4212575
OTO - NOTNLM
OT  - A1C
OT  - Clinical Trial(s)
OT  - Endocrinology Diabetes
OT  - Hispanic
EDAT- 2014/12/03 06:00
MHDA- 2014/12/03 06:01
PMCR- 2014/04/16
CRDT- 2014/12/03 06:00
PHST- 2014/02/05 00:00 [received]
PHST- 2014/03/04 00:00 [accepted]
PHST- 2014/12/03 06:00 [entrez]
PHST- 2014/12/03 06:00 [pubmed]
PHST- 2014/12/03 06:01 [medline]
PHST- 2014/04/16 00:00 [pmc-release]
AID - bmjdrc-2014-000020 [pii]
AID - 10.1136/bmjdrc-2014-000020 [doi]
PST - epublish
SO  - BMJ Open Diabetes Res Care. 2014 Apr 16;2(1):e000020. doi: 
      10.1136/bmjdrc-2014-000020. eCollection 2014.