Format

Send to

Choose Destination
Diabetologia. 2013 Jun;56(6):1226-35. doi: 10.1007/s00125-013-2890-4. Epub 2013 Apr 8.

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

Author information

1
Division of Endocrinology, Metabolism and Nutrition, Duke University Medical Center, DUMC Box 3850, 2400 Pratt Street, Room 7039, North Pavilion, Durham, NC 27705, USA.

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.

PMID:
23564296
DOI:
10.1007/s00125-013-2890-4
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Springer
Loading ...
Support Center