Display options
Cite
Davidson JA, Lajara R, Aguilar RB, et al. 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. BMJ Open Diabetes Res Care. 2014;2(1):e000020doi: 10.1136/bmjdrc-2014-000020.
Davidson, J. A., Lajara, R., Aguilar, R. B., Mattheus, M., Woerle, H. J., & von Eynatten, M. (2014). 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. BMJ open diabetes research & care, 2(1), e000020. https://doi.org/10.1136/bmjdrc-2014-000020
Davidson, Jaime A, et al. "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." BMJ open diabetes research & care vol. 2,1 (2014): e000020. doi: https://doi.org/10.1136/bmjdrc-2014-000020
Davidson JA, Lajara R, Aguilar RB, Mattheus M, Woerle HJ, von Eynatten M. 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. BMJ Open Diabetes Res Care. 2014 Apr 16;2(1):e000020. doi: 10.1136/bmjdrc-2014-000020. eCollection 2014. PMID: 25452864; PMCID: PMC4212575.
Copy Download .nbib Format: NLM
Share it on

BMJ Open Diabetes Res Care. 2014 Apr 16;2(1):e000020. doi: 10.1136/bmjdrc-2014-000020. eCollection 2014.

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.

BMJ open diabetes research & care

Jaime A Davidson, Rosemarie Lajara, Richard B Aguilar, Michaela Mattheus, Hans-Juergen Woerle, Maximilian von Eynatten

Affiliations

  1. The University of Texas Southwestern Medical Center , Dallas, Texas , USA.
  2. Diabetes America-PA President , Plano, Texas , USA.
  3. Diabetes Nation , Sisters, Oregon , USA.
  4. Boehringer Ingelheim Pharma GmbH & Co. KG , Ingelheim , Germany.
  5. Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield, Connecticut , USA.

PMID: 25452864 PMCID: PMC4212575 DOI: 10.1136/bmjdrc-2014-000020

Abstract

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.

Keywords: A1C; Clinical Trial(s); Endocrinology Diabetes; Hispanic

References

  1. Lancet. 2012 Aug 4;380(9840):475-83 - PubMed
  2. Metabolism. 1990 Aug;39(8):842-7 - PubMed
  3. Diabetes Obes Metab. 2012 Jun;14(6):565-74 - PubMed
  4. Diabetes Educ. 2012 Mar-Apr;38(2):263-70 - PubMed
  5. Diabetes. 1997 Jan;46(1):63-9 - PubMed
  6. Diabetes Care. 2013 Dec;36(12):3875-81 - PubMed
  7. Diabetes. 1996 Jun;45(6):742-8 - PubMed
  8. Curr Med Res Opin. 2013 Aug;29(8):921-9 - PubMed
  9. Diabetes Obes Metab. 2009 Jun;11(6):527-33 - PubMed
  10. Diabetes Care. 2013 Feb;36(2):237-44 - PubMed
  11. Curr Med Res Opin. 2012 Jun;28(6):969-77 - PubMed
  12. Diabet Med. 2011 Nov;28(11):1352-61 - PubMed
  13. Diabetes Res Clin Pract. 2013 Jun;100(3):306-29 - PubMed
  14. Fam Med. 2007 May;39(5):351-6 - PubMed
  15. Diabetes Care. 2002 Dec;25(12):2184-90 - PubMed
  16. Endocr Pract. 2014 May;20(5):412-20 - PubMed
  17. J Am Soc Nephrol. 2007 May;18(5):1540-6 - PubMed
  18. Cardiovasc Diabetol. 2012 Jan 10;11:3 - PubMed
  19. Curr Med Res Opin. 2011 May;27(5):969-79 - PubMed
  20. Kidney Int. 2004 Jun;65(6):2309-20 - PubMed
  21. J Clin Endocrinol Metab. 2003 Jul;88(7):3251-7 - PubMed
  22. Int J Clin Pract. 2013 Dec;67(12):1283-93 - PubMed
  23. Diabetes Care. 2013 Nov;36(11):3460-8 - PubMed
  24. Int J Clin Pract. 2012 Aug;66(8):731-740 - PubMed
  25. West J Nurs Res. 2002 Dec;24(8):840-58; discussion 858-67 - PubMed
  26. Diabetes Obes Metab. 2012 Apr;14 (4):348-57 - PubMed
  27. South Med J. 2007 Aug;100(8):812-20 - PubMed
  28. Vital Health Stat 10. 2012 Dec;(256):1-218 - PubMed
  29. Diabetes Obes Metab. 2012 Dec;14(12):1145-54 - PubMed
  30. Ethn Dis. 2009 Autumn;19(4):466-72 - PubMed
  31. Clin Ther. 2012 Sep;34(9):1909-19.e15 - PubMed
  32. PLoS One. 2012;7(8):e39589 - PubMed
  33. Diabetes Obes Metab. 2011 Jan;13(1):65-74 - PubMed
  34. Ther Adv Endocrinol Metab. 2012 Aug;3(4):113-24 - PubMed
  35. Lancet. 2013 Oct 26;382(9902):1413-23 - PubMed

Publication Types