Gender Bias in Clinical Trials of Sodium-Glucose Cotransporter 2 Inhibitors for the Treatment of Type 2 Diabetes Mellitus: A Systematic Review
Abstract
Aims: The study is aimed at assessing gender bias in Phase III clinical trials (CTs) of sodium-glucose cotransporter type 2 (iSGLT2) inhibitors in adults with Type 2 diabetes mellitus (T2DM). Methods: We searched PubMed and EMBASE databases until June 2023. To estimate sex bias in recruitment, the difference between F-Particip (fraction of women recruited) and F-Prev (prevalence fraction of women with T2DM) was calculated. A significant sex bias in recruitment was considered to exist when the difference between F-Particip and F-Prev was greater than 0.05, 0.1, and 0.2. The analysis was considered to have a sex bias when the efficacy variables were not analyzed by sex. Gender of the first, last, and corresponding author was also assessed. Results: In total, 70 articles met all inclusion criteria. Sex bias in recruitment showed variable results depending on the reference value. No significant sex bias in recruitment was found in the total number of included patients. Examining each CT individually, using values of significant sex bias in recruitment of ±0.05, ±0.1, or ±0.2, we found that 41.4%, 20%, and 5.7% of the trials, respectively, showed this bias. In 34.3% of the articles, women were the first, last, or corresponding authors. Sex-based analysis of the results was performed in five studies. Conclusions: Although the proportion of women included in iSGLT2 CTs seems acceptable, gender bias persists in the analysis of variables and in the study authors. However, the lack of…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
Read the paper
Related studies
- The Role of AMPK Activation for Cardioprotection in Doxorubicin-Induced Cardiotoxicity
- Hypoglycemic medicines in the treatment of Alzheimer’s disease: Pathophysiological links between AD and glucose metabolism
- Isorhamnetin Reduces Glucose Level, Inflammation, and Oxidative Stress in High-Fat Diet/Streptozotocin Diabetic Mice Model
- Modulating Sirtuin Biology and Nicotinamide Adenine Diphosphate Metabolism in Cardiovascular Disease—From Bench to Bedside
- Characterization of the SGLT2 Interaction Network and Its Regulation by SGLT2 Inhibitors: A Bioinformatic Analysis
- Early Treatment with Empagliflozin and GABA Improves β-Cell Mass and Glucose Tolerance in Streptozotocin-Treated Mice
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.