Article

Diabetologia

, Volume 56, Issue 6, pp 1226-1235

Are current clinical trials in diabetes addressing important issues in diabetes care?

  • W. C. LakeyAffiliated withDivision of Endocrinology, Metabolism and Nutrition, Duke University Medical CenterEndocrinology Section, Durham Veterans Affairs Medical Center
  • , K. BarnardAffiliated withDivision of Endocrinology, Metabolism and Nutrition, Duke University Medical CenterEndocrinology Section, Durham Veterans Affairs Medical CenterDivision of Endocrinology, Diabetes and Metabolism, Stellenbosch University
  • , B. C. BatchAffiliated withDivision of Endocrinology, Metabolism and Nutrition, Duke University Medical CenterEndocrinology Section, Durham Veterans Affairs Medical Center
  • , K. ChiswellAffiliated withDuke Clinical Research Institute
  • , A. TasneemAffiliated withDuke Clinical Research Institute
  • , J. B. GreenAffiliated withDivision of Endocrinology, Metabolism and Nutrition, Duke University Medical CenterEndocrinology Section, Durham Veterans Affairs Medical CenterDuke Clinical Research Institute Email author 

Abstract

Aims/hypothesis

Clinical trials assessing interventions for treating and preventing diabetes mellitus and its complications are needed to inform evidence-based practice. To examine whether current studies adequately address these needs, we conducted a descriptive analysis of diabetes-related trials registered with ClinicalTrials.gov from 2007 to 2010.

Methods

From a dataset including 96,346 studies registered in ClinicalTrials.gov downloaded on 27 September, 2010, a subset of 2,484 interventional trials was created by selecting trials with disease condition terms relevant to diabetes.

Results

Of the diabetes-related trials, 74.8% had a primarily therapeutic purpose while 10% were preventive. Listed interventions included drugs (63.1%) and behavioural (11.7%). Most trials were designed to enrol ≤500 (91.1%) or ≤100 (58.6%) participants, with mean/median times to completion of 1.8/1.4 years. Small percentages of trials targeted persons aged ≤18 years (3.7%) or ≥65 years (0.6%), while 30.8% excluded patients >65 years and the majority excluded those >75 years. Funding sources included industry (50.9%), NIH (7.5%) or other, with most being single-centre trials of other sponsorship (37.7%) or industry-funded multicentre studies (27.4%). A small number of trials (1.4%) listed primary outcomes including mortality or clinically significant cardiovascular complications. The distribution of trials by global region and US state does not correlate with prevalence of diabetes.

Conclusions/interpretation

The majority of diabetes-related trials include small numbers of participants, exclude those at the extremes of age, are of short duration, involve drug therapy rather than preventive or non-drug interventions and do not focus upon significant cardiovascular outcomes. Recently registered diabetes trials may not sufficiently address important diabetes care issues or involve affected populations.

Keywords

Clinical trials Diabetes mellitus Evidence-based medicine Registry