EFFICACY AND SAFETY OF LINAGLIPTIN IN BLACK/AFRICAN AMERICAN PATIENTS WITH TYPE 2 DIABETES: A 6-MONTH, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objective: Although black/African American individuals are disproportionately affected by type 2 diabetes, there is scant clinical trial information available on anti-diabetes therapies in this group. We compared linagliptin with placebo in black/African American adults who were treatment-naIve or receiving one oral antidiabetes drug. Methods: Of 226 patients randomized to 24 weeks' linagliptin 5 mg/day or placebo, 208 had baseline and at least one on-treatment glycated hemoglobin (HbA(1c)) measurement. Mean baseline HbA(1c) was 8.6% in the linagliptin group (n = 98) and 8.68% in the placebo group (n = 110). The primary outcome was change in HbA(1c) from baseline to week 24. Results: By week 24, mean HbA(1c) changes were -0.84% with linagliptin and -0.25% with placebo (treatment difference, -0.58%; P<.001), and more patients in the linagliptin group achieved HbA(1c) <7.0% (26.8% vs. 8.3%; P=.001) or an HbA(1c) reduction >= 0.5% (54.1% vs. 30.0%; P<.001). Mean weight loss was -1.1 kg in both groups. During the treatment period, 8 of 98 linagliptin-group patients and 17 of 110 placebo-group patients required rescue therapy (odds ratio, 0.5; P=.14). For postprandial glucose, values were available for few patients (11 placebo, 10 linagliptin), and thus the between-group difference was associated with wide confidence intervals (CIs) (difference, -1.97 mg/dL; 95% CI, -53.80 to 49.86; P=.94). In the overall study population, a similar proportion of patients in both groups had adverse events (58.5% vs. 61.7%); most events were mild or moderate and considered unrelated to study drug. Investigator-defined hypoglycemia was rare (3 linagliptin-group patients and 1 placebo-group patient), with no severe events (requiring external assistance). Conclusion: This study confirms that linagliptin is efficacious and well tolerated in black/African American patients with type 2 diabetes.