Pediatric drug development programs for type 2 diabetes

A review

Michael Christensen, Brandi Franklin, Jeremiah D. Momper, Michael D. Reed

Research output: Contribution to journalReview article

8 Citations (Scopus)

Abstract

Considerable progress has been made in pediatric drug development. Despite these gains there remain certain therapeutic areas where a high percentage of drugs approved for use in adults do not gain approval for use in children. Lack of sufficient US Food and Drug Administration (FDA)-approved labeling correlates with diminished therapeutic efficacy and increased risk for adverse drug reactions. Despite the increasing prevalence and important clinical challenge with pediatric type 2 diabetes mellitus (T2DM), only 1 drug (metformin) of the first 4 T2DM drugs to complete testing in children gained FDA approval. This analysis reviews 4 pediatric drug development programs for orally administered antidiabetic agents that have undergone FDA review and discusses factors influencing failure to meet specified end points for approval. Recommendations to guide future study are also provided.

Original languageEnglish (US)
Pages (from-to)731-738
Number of pages8
JournalJournal of Clinical Pharmacology
Volume55
Issue number7
DOIs
StatePublished - Jul 1 2015

Fingerprint

Type 2 Diabetes Mellitus
Pediatrics
United States Food and Drug Administration
Pharmaceutical Preparations
Drug Approval
Metformin
Drug-Related Side Effects and Adverse Reactions
Hypoglycemic Agents
Therapeutics

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Pediatric drug development programs for type 2 diabetes : A review. / Christensen, Michael; Franklin, Brandi; Momper, Jeremiah D.; Reed, Michael D.

In: Journal of Clinical Pharmacology, Vol. 55, No. 7, 01.07.2015, p. 731-738.

Research output: Contribution to journalReview article

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