Objective: In the United States, black/African American individuals are more likely than whites to develop type 2 diabetes mellitus (T2DM), and have higher rates of complications, but are under-represented in clinical trials. The design of a trial comparing the efficacy and safety of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin 5 mg/day with placebo in this patient group, and the characteristics of the patients enrolled are reported.
Research design and methods: This United States, multicenter, 24-week, randomized, double-blind study enrolled adults with T2DM who self-reported their race as black or African American, were receiving ≤ 1 oral antidiabetes drug, had a body mass index ≤ 45 kg/m(2) and glycosylated hemoglobin (HbA(1c)) of 7.5 - 11% at screening.
Main outcome measures: The primary efficacy endpoint is the change of HbA(1c) from baseline to week 24.
Baseline data: A total of 226 patients were randomized and received ≥ 1 study drug dose. The mean age was 54 years (standard deviation: 9.9 years), and 54% were men. The mean HbA(1c) was 8.75% (standard deviation: 1.10%). Approximately half the patients (52%) had mild or moderate renal impairment and the majority (72%) had hypertension.
Conclusions: To the authors' knowledge, this is the first trial of any oral antidiabetes drug specifically conducted in black/African American patients.
Trial registration: ClinicalTrials.gov NCT01194830.