title: Effect of race and ethnicity on vildagliptin efficacy: A pooled analysis of phase II and III studies.
abstract: To determine the impact of race and ethnicity on the efficacy, body weight and hypoglycaemia incidence with vildagliptin treatment in patients with type 2 diabetes mellitus using patient-level data from the vildagliptin clinical trial programme.
  
  
  
  Data from 22 randomized, placebo-controlled global and local (Japan, China) registration studies of vildagliptin (50 mg once-daily or twice-daily) of ≥12-week duration were analysed by race (Caucasian [n = 2764] and Asian [n = 2232]) and by ethnicity (Japanese, Chinese, and Indian). The placebo-subtracted differences in the change in glycated haemoglobin (HbA1c) and body weight from baseline to week 12 or week 24 were evaluated by race or ethnicity using repeated measure analysis of unstructured covariance. Hypoglycaemia incidences were summarized using descriptive statistics.
  
  
  
  The HbA1c reduction from baseline with vildagliptin was similar across the racial/ethnic subgroups (-0.83% ± 0.02% to -1.01% ± 0.05%). Placebo-corrected HbA1c reduction was similar between Caucasian (-0.68% ± 0.03%) and Asian (-0.80% ± 0.03%) patients ( P value for interaction = .56); analysis by race and ethnicity showed better efficacy ( P < .02) in Japanese patients. Japanese patients were drug-naïve and treated with a single oral anti-diabetes drug only; they showed no response to placebo. Weight neutrality of vildagliptin was demonstrated in all groups (0.47 ± 0.11 kg to -0.29 ± 0.08 kg). Hypoglycaemic events (≥1) were infrequent in all ethnic subgroups.
  
  
  
  The glycaemic efficacy of vildagliptin was similar in Caucasian and Asian patients. The slightly better efficacy observed in Japanese patients was driven by the absence of placebo effect and might be explained by their earlier stage of diabetes compared to other subgroups.
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Plamen
authors.initials: P
authors.lastname: Kozlovski
authors.affiliation: School of Public Health, University of São Paulo, São Paulo, Brazil.
authors.forename: Marilia
authors.initials: M
authors.lastname: Fonseca
authors.affiliation: Dr. Mohan's Diabetes Specialities Centre, Chennai, India.
authors.forename: Viswanathan
authors.initials: V
authors.lastname: Mohan
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Valentina
authors.initials: V
authors.lastname: Lukashevich
authors.affiliation: The Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Odawara
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Päivi M
authors.initials: PM
authors.lastname: Paldánius
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kothny
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D002681:China; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D005006:Ethnicity; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007194:India; D007328:Insulin / Q000627:therapeutic use; D007564:Japan; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000627:therapeutic use*; D044469:Racial Groups; D016032:Randomized Controlled Trials as Topic; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D016896:Treatment Outcome; D000077597:Vildagliptin; D044465:White People
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D013453:Sulfonylurea Compounds; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human
keywords: Asia; Caucasian; China; DPP-4 inhibitor; India; Japan; ethnicity; race