Scientific and ethical issues in add-on designs for antidiabetic drugs

Eur J Clin Pharmacol. 2022 Sep;78(9):1399-1401. doi: 10.1007/s00228-022-03351-w. Epub 2022 Jun 22.

Abstract

This editorial describes the clinical trials related to antidiabetic drugs, most of them following an "add-on" design of where the new drug is added to metformin and the comparative arm is metformin plus placebo. Many drugs are already approved for therapy following this design; the authors believe that it is unethical to continue this trend because it makes it impossible to stratify the many antidiabetic drugs according to their efficacy and toxicity.

Keywords: Add-on design; Antidiabetic drugs; Clinical trial; Type 2 diabetes.

Publication types

  • Editorial

MeSH terms

  • Clinical Trials as Topic
  • Diabetes Mellitus, Type 2* / drug therapy
  • Drug Therapy, Combination
  • Humans
  • Hypoglycemic Agents* / therapeutic use
  • Metformin / therapeutic use
  • Sulfonylurea Compounds

Substances

  • Hypoglycemic Agents
  • Sulfonylurea Compounds
  • Metformin