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Diabetes clinical trials: helped or hindered by the current shift in regulatory requirements?

Faiez Zannad1, Wendy Gattis Stough, Stuart J Pocock

  • 1INSERM, Centre d'Investigation Clinique 9501 and Unité 961, Centre Hospitalier Universitaire, and the Department of Cardiology, Nancy University, Hôpital Jeanne d' Arc, 54200 Toul, Nancy, France. f.zannad@chu-nancy.fr

European Heart Journal
|March 17, 2012
PubMed

Insights

Glycaemic control is insufficient for measuring cardiovascular risk reduction in type 2 diabetes. New trials must focus on meaningful clinical benefits beyond blood sugar levels for diabetes treatments.

Area of Science:

  • Endocrinology
  • Cardiology
  • Clinical Trials

Background:

  • Glycaemic control is an inadequate surrogate marker for cardiovascular event reduction in type 2 diabetes.
  • Current therapeutic approaches have not successfully linked glycaemic control to reduced cardiovascular risk.
  • Concerns about cardiovascular risks associated with some anti-diabetic agents have altered regulatory requirements.

Purpose of the Study:

  • To highlight the inadequacy of glycaemic control as a surrogate marker for cardiovascular outcomes in type 2 diabetes.
  • To advocate for regulatory frameworks that prioritize demonstration of clinical benefits in diabetes trials.
  • To propose improvements in clinical trial design and regulatory standards for anti-diabetic therapies.

Main Methods:

  • Review of existing clinical trial data and regulatory requirements for anti-diabetic therapies.
  • Analysis of the limitations of surrogate markers like glycaemic control, serum creatinine, and micro-albuminuria.
  • Discussion of potential strategies to encourage long-term clinical trials.

Main Results:

  • Glycaemic control, serum creatinine, micro-albuminuria, and retinopathy changes are insufficient surrogates for cardiovascular benefits.
  • Existing regulatory requirements emphasize safety but often neglect the need to demonstrate tangible clinical benefits.
  • There is a lack of therapeutic approaches effectively addressing both glycaemic control and cardiovascular risk in type 2 diabetes.

Conclusions:

  • Regulators should encourage long-term trials by considering incentives like extended patent protection.
  • Redefining therapeutic targets to include patient-meaningful outcomes is crucial.
  • Collaborative efforts are needed to address challenges in trial design, duration, and ethical considerations for chronic conditions like diabetes.

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