title: Black/African American patients with type 2 diabetes mellitus: study design and baseline patient characteristics from a randomized clinical trial of linagliptin.
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.
  
  
  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.
  
  
  METHODS
  The primary efficacy endpoint is the change of HbA(1c) from baseline to week 24.
  
  
  METHODS
  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.
authors.affiliation: Medical Investigations, Inc., Little Rock, AR 72205, USA. jthrashermd@yahoo.com
authors.forename: James
authors.initials: J
authors.lastname: Thrasher
authors.forename: Kristen
authors.initials: K
authors.lastname: Daniels
authors.forename: Sanjay
authors.initials: S
authors.lastname: Patel
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Whetteckey
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D000369:Aged, 80 and over; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069476:Linagliptin; D008297:Male; D008875:Middle Aged; D011687:Purines / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D011687:Purines; D011799:Quinazolines; D000069476:Linagliptin