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Exclusion of older adults from ongoing clinical trials about type 2 diabetes mellitus

Alfonso J Cruz-Jentoft1, Marina Carpena-Ruiz, Beatriz Montero-Errasquín

  • 1Department of Geriatrics, Hospital Universitario Ramón y Cajal, Madrid, Spain. alfonsojose.cruz@salud.madrid.org

Journal of the American Geriatrics Society
|April 18, 2013
PubMed
Abstract

Insights

Older adults are frequently excluded from type 2 diabetes mellitus clinical trials, often due to poorly justified age limits or comorbidities. This limits evidence for treating complex older patients.

Area of Science:

  • Gerontology
  • Clinical Trials
  • Endocrinology

Background:

  • Clinical trials are crucial for evidence-based medicine.
  • Older adults with type 2 diabetes mellitus (T2DM) are a growing population with complex health needs.
  • Exclusion criteria in trials can limit the generalizability of findings.

Purpose of the Study:

  • To determine the extent to which older individuals are excluded from ongoing clinical trials for type 2 diabetes mellitus.
  • To analyze the justification of exclusion criteria used in these trials.

Main Methods:

  • A cohort study analyzed data from the World Health Organization Clinical Trials Registry Platform.
  • The Participation of the Elderly in Clinical Trials methodology was used.
  • Exclusion criteria, including arbitrary age limits and those related to comorbidities, were assessed for justification.

Main Results:

  • 65.7% of 440 T2DM trials excluded individuals based on arbitrary upper age limits.
  • Exclusion due to comorbidity was common (76.8%) and often poorly justified (53.6%).
  • Only 1.4% of trials were specifically designed for older adults.

Conclusions:

  • Older individuals are frequently excluded from T2DM clinical trials, exceeding rates seen in other age-related diseases.
  • This exclusion hinders the development of evidence-based treatment guidelines for elderly patients with T2DM.
  • International recommendations to include older adults in trials are not being adequately followed.

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