title: Efficacy and Safety of Linagliptin in Black/African American Patients with Type 2 Diabetes: A 6-month, Randomized, Double-blind, Placebo-controlled Study.
abstract: OBJECTIVE
  Although black/African American individuals are disproportionately affected by type 2 diabetes, there is scant clinical trial information available on antidiabetes therapies in this group. We compared linagliptin with placebo in black/African American adults who were treatment-naïve 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 (HbA1c) measurement. Mean baseline HbA1c was 8.6% in the linagliptin group (n = 98) and 8.68% in the placebo group (n = 110). The primary outcome was change in HbA1c from baseline to week 24.
  
  
  RESULTS
  By week 24, mean HbA1c 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 HbA1c <7.0% (26.8% vs. 8.3%; P = .001) or an HbA1c 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).
  
  
  CONCLUSIONS
  This study confirms that linagliptin is efficacious and well tolerated in black/African American patients with type 2 diabetes.
authors: Medical Investigations Inc., Little Rock, Arkansas.
authors: James
authors: J
authors: Thrasher
authors: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut.
authors: Kristen
authors: K
authors: Daniels
authors: Boehringer Ingelheim Ltd., Bracknell, United Kingdom.
authors: Sanjay
authors: S
authors: Patel
authors: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut.
authors: Jacqueline
authors: J
authors: Whetteckey
authors: Boehringer Ingelheim GmbH and Co., KG, Ingelheim, Germany.
authors: Hans-Juergen
authors: HJ
authors: Woerle
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D044383:Black People; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000069476:Linagliptin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069476:Linagliptin; C517652:hemoglobin A1c protein, human