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. Issue 1 (16th April 2014)

• Record Type: Journal Article
• Authors: Davidson, Jaime A; Lajara, Rosemarie; Aguilar, Richard B; Mattheus, Michaela; Woerle, Hans-Juergen; von Eynatten, Maximilian
• Is Part Of: BMJ open diabetes research and care. Volume 2:Issue 1(2014)
• Publication Date: 2014-04-16
• Subjects: A1C -- Hispanic -- Clinical Trial(s) -- Endocrinology Diabetes; Diabetes -- Periodicals; 616.462005
• DOI: 10.1136/bmjdrc-2014-000020
• Languages: English
• ISSNs: 2052-4897

Abstract

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.