title: Representation of people of South Asian origin in cardiovascular outcome trials of glucose-lowering therapies in Type 2 diabetes.
abstract: Our aim was to investigate the proportional representation of people of South Asian origin in cardiovascular outcome trials of glucose-lowering drugs or strategies in Type 2 diabetes, noting that these are among the most significant pieces of evidence used to formulate the guidelines on which clinical practice is largely based.
  
  
  
  We searched for cardiovascular outcome trials in Type 2 diabetes published before January 2015, and extracted data on the ethnicity of participants. These were compared against expected values for proportional representation of South Asian individuals, based on population data from the USA, from the UK, and globally.
  
  
  
  Twelve studies met our inclusion criteria and, of these, eight presented a sufficiently detailed breakdown of participant ethnicity to permit numerical analysis. In general, people of South Asian origin were found to be under-represented in trials compared with UK and global expectations and over-represented compared with US expectations. Among the eight trials for which South Asian representation could be reliably estimated, seven under-represented this group relative to the 11.2% of the UK diabetes population estimated to be South Asian, with the representation in these trials ranging from 0.0% to 10.0%.
  
  
  
  Clinicians should exercise caution when generalizing the results of trials to their own practice, with regard to the ethnicity of individuals. Efforts should be made to improve reporting of ethnicity and improve diversity in trial recruitment, although we acknowledge that there are challenges that must be overcome to make this a reality.
authors.affiliation: Leicester Diabetes Centre, University of Leicester, Leicester, UK.
authors.forename: K
authors.initials: K
authors.lastname: Khunti
authors.affiliation: Aston Research Centre for Healthy Ageing, Aston University, Birmingham, UK.
authors.forename: S
authors.initials: S
authors.lastname: Bellary
authors.affiliation: Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: M A
authors.initials: MA
authors.lastname: Karamat
authors.affiliation: Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: K
authors.initials: K
authors.lastname: Patel
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: V
authors.initials: V
authors.lastname: Patel
authors.affiliation: SB Communications Group, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Jones
authors.affiliation: SB Communications Group, London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Gray
authors.affiliation: SB Communications Group, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Shepherd
authors.affiliation: University Hospital Birmingham, Birmingham, UK.
authors.forename: W
authors.initials: W
authors.lastname: Hanif
mesh_terms: D001208:Asia / Q000453:epidemiology / Q000208:ethnology; D044466:Asian People; D002318:Cardiovascular Diseases / Q000150:complications / Q000453:epidemiology / Q000208:ethnology / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000208:ethnology; D003925:Diabetic Angiopathies / Q000453:epidemiology / Q000208:ethnology / Q000517:prevention & control*; D058065:Diabetic Cardiomyopathies / Q000453:epidemiology / Q000208:ethnology / Q000517:prevention & control*; D019317:Evidence-Based Medicine; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D012306:Risk
chemical_list: D007004:Hypoglycemic Agents