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The end point is just the beginning

Douglas Muchmore1

  • 1Halozyme Therapeutics, Inc., San Diego, California 92121, USA. dmuchmore@halozyme.com

Journal of Diabetes Science and Technology
|October 27, 2011
PubMed

Insights

Developing new diabetes drugs is costly. A proposed composite endpoint combines glycosylated hemoglobin (A1C) and hypoglycemia risk for more meaningful clinical trial results.

Area of Science:

  • Endocrinology
  • Clinical Pharmacology
  • Biostatistics

Background:

  • Drug registration trials are resource-intensive.
  • Glycosylated hemoglobin (A1C) is an accepted surrogate endpoint for glycemic control in diabetes trials.
  • Current guidelines assess A1C efficacy and hypoglycemia safety separately, limiting interpretability.

Purpose of the Study:

  • To propose a composite endpoint for diabetes clinical trials.
  • To integrate glycemic control (A1C) and hypoglycemia risk into a single measure.
  • To discuss the advantages and disadvantages of this novel approach.

Main Methods:

  • Literature review of current regulatory guidance for diabetes trials.
  • Conceptualization of a composite endpoint integrating A1C and hypoglycemia.
  • Discussion of the potential benefits and limitations of the proposed endpoint.

Main Results:

  • A composite endpoint, such as "percentage of patients achieving A1C <7% without unacceptable hypoglycemia," is proposed.
  • This approach offers a more holistic view of treatment efficacy and safety.
  • Separate assessment of A1C and hypoglycemia may not fully reflect clinical utility.

Conclusions:

  • A composite endpoint can provide a more comprehensive evaluation of diabetes treatments.
  • Integrating efficacy and safety endpoints may improve the efficiency and relevance of clinical trials.
  • Further validation and discussion are needed to implement such composite endpoints in regulatory practice.

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