Clinical Trial Risk in Type-2 Diabetes: Importance of Patient History

Authors

  • Emmanuel O. Aiyere Department of Biology, University of Toronto at Mississauga, Toronto, ON
  • Jay Silverberg Sunnybrook Health Sciences Centre, Toronto, ON
  • Safina Ali Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada
  • Jayson L. Parker Department of Biology, University of Toronto at Mississauga, Toronto, ON

DOI:

https://doi.org/10.18433/J3HG73

Abstract

Purpose. To determine the risk of clinical trial failure for drugs developed for type-2 diabetes.  Methods. Drugs were investigated by reviewing phase I to phase III studies that were conducted between 1998 and February 2013. The clinical trial success rates were calculated and compared to the industry standard. The drugs were classified into GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors and “Other”. The exclusion criteria for drugs in this study: Drugs that were started in phase I studies prior to January 1998 for this indication and drugs whose primary indications were not for the control of blood glucose levels.  Results. Data was extracted from clinicaltrials.gov; there were a total of 131 drug candidates that fit our specified criteria, of which 8 received FDA approval. The cumulative success rate for molecules developed for type-2 diabetes is 10%. Small molecules were more successful than biologics. A strong disparity was observed in phase III, with studies that utilised treatment naïve patients having a 40% success rate, compared to an 83% success rate in patients who have had previous anti-hyperglycemic exposure.  Conclusions. 1 in 10 drugs that enter clinical testing in this disease will be approved. The DPP-4 inhibitor class of drugs had the highest success rate of all drug classes with a 63% cumulative success rate; while treatment naïve patients carried the greatest clinical trial risk.  Keywords: Clinical trials, Type-2 diabetes, Drug development, Clinical trial risk.

 

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Published

2014-08-25

How to Cite

Aiyere, E. O., Silverberg, J., Ali, S., & Parker, J. L. (2014). Clinical Trial Risk in Type-2 Diabetes: Importance of Patient History. Journal of Pharmacy & Pharmaceutical Sciences, 17(3), 393–400. https://doi.org/10.18433/J3HG73

Issue

Section

Clinical Pharmacology and Therapeutics