Exclusion of older persons from randomized controlled trials in type 2 diabetes: A cross-sectional study

IF 5.4 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes, Obesity & Metabolism Pub Date : 2024-12-26 DOI:10.1111/dom.16137

Jan Borysowski PhD, Danuta Kłosowska MS, Leszek Pączek PhD, Michał Ordak PhD, Edward Franek PhD

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Abstract

Background

Prevalence of type 2 diabetes increases with age. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) promote the enrollment of older patients to randomized controlled trials (RCTs) in diabetes. The objective of this study was to assess the eligibility criteria limiting the inclusion of older adults to RCTs in type 2 diabetes.

Materials and Methods

This cross-sectional analysis of ClinicalTrials.gov included phase 2, 3 and 4 RCTs of drugs and biologicals, with enrollment ≥100, registered at ClinicalTrials.gov and started from 2014 through 2023.

Results

A total of 278/594 (46.8%) trials had a limit of 90 years of age or less (primary outcome). The odds of the age limits were higher in RCTs funded from non-commercial sources (adjusted odds ratio (aOR), 2.83, 95% confidence interval (CI), 1.77–4.52; p < 0.001) and phase 2 trials (aOR, 2.38; 95% CI, 1.49–3.81; p < 0.001). A total of 542/594 (91.2%) trials had other relevant exclusion criteria, mostly those concerning comorbidities common in older patients (secondary outcome). However, none of the RCTs excluded patients with frailty which is a key factor determining the prognosis of older patients with diabetes. Only two trials enrolled solely older persons.

Conclusions

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.

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将老年人排除在2型糖尿病随机对照试验之外：一项横断面研究。

背景：2型糖尿病的患病率随着年龄的增长而增加。美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）都提倡老年患者参加糖尿病随机对照试验（rct）。本研究的目的是评估限制老年人纳入2型糖尿病随机对照试验的资格标准。材料和方法：ClinicalTrials.gov的横断面分析纳入了药物和生物制品的2期、3期和4期随机对照试验，入组≥100人，在ClinicalTrials.gov注册，从2014年到2023年。结果：共有278/594（46.8%）项试验的年龄限制为90岁或以下（主要结局）。非商业来源资助的随机对照试验中，年龄限制的几率更高(调整优势比（aOR）， 2.83, 95%可信区间（CI）， 1.77-4.52；结论：大多数2型糖尿病的随机对照试验都有限制老年患者入组的资格标准。应取消年龄限制，并根据科学证明的标准排除患者，特别是那些涉及合并症和虚弱的患者。此外，新药对老年多病和/或虚弱患者的益处和危害应在专门的4期试验中进行评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.