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Abstract
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/m2 and glycosylated hemoglobin (HbA1c) of 7.5 – 11% at screening.
Main outcome measures: The primary efficacy endpoint is the change of HbA1c 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 HbA1c 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.
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Acknowledgements
Writing and editorial assistance was provided by L Merkel and G Thompson of Envision Scientific Solutions, which was contracted and compensated by Boehringer Ingelheim Pharmaceuticals, Inc. for these services. The trial is registered with clinicaltrials.gov as NCT01194830. The design of this study was presented as an abstract at the National Medical Association 2010 Scientific Assembly (Orlando, Florida; July 31 – August 4, 2010).