Exclusion of older persons from randomized controlled trials in type 2 diabetes: A cross‐sectional study
Authors' conclusion
Most RCTs in type 2 diabetes have the eligibility criteria limiting the enrollment of older patients. The age limits should be eliminated and patients should be excluded based on scientifically justified criteria especially those concerning comorbidities and frailty. Moreover, the benefits and harms of new drugs in older patients with multimorbidity and/or frailty should be assessed in dedicated phase 4 trials.
Study context
- Population
- Phase 2, 3 and 4 randomized controlled trials (RCTs) of drugs and biologicals in T2D, enrollment ≥100, registered at ClinicalTrials.gov, started 2014–2023
- Participants
- 594 RCTs
- Outcome
- Trials with an age limit of 90 years or less
Methodological detailsanalysis of ClinicalTrials.gov registrations
- Analysis of ClinicalTrials.gov registrations
Main finding
As reported in the abstract
Trials with an age limit of 90 years of age or less
278 of 594
46.8%
Higher odds of age limits in non-commercially funded RCTs: aOR, 95% CI
2.83
1.77–4.52p < 0.001
Higher odds of age limits in phase 2 trials: aOR, 95% CI
2.38
1.49–3.81p < 0.001
Observational data: associations, not effects.
Secondary outcomes
Other relevant exclusion criteria, mostly comorbidities common in older patients
- Trials with other relevant exclusion criteria
- 542/594 (91.2%)
- RCTs excluding patients with frailty
- 0
- Trials enrolling solely older persons
- 2
Original publication
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