title: Pediatric drug development programs for type 2 diabetes: A review.
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.
authors.affiliation: Department of Clinical Pharmacy and the Center for Pediatric Pharmacokinetics and Therapeutics, University of Tennessee Health Science Center, Memphis,, TN, USA.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Christensen
authors.affiliation: Department of Clinical Pharmacy and the Center for Pediatric Pharmacokinetics and Therapeutics, University of Tennessee Health Science Center, Memphis,, TN, USA.
authors.forename: Brandi E
authors.initials: BE
authors.lastname: Franklin
authors.affiliation: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla,, CA, USA.
authors.forename: Jeremiah D
authors.initials: JD
authors.lastname: Momper
authors.affiliation: The Division of Clinical Pharmacology and Toxicology and the Rebecca D. Considine Research Institute, Akron Children's Hospital, Akron,, OH, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Reed
mesh_terms: D002648:Child; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D017277:Drug Approval; D015195:Drug Design; D004348:Drug Labeling; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D007004:Hypoglycemic Agents
keywords: adolescents; clinical trial design; type 2 diabetes mellitus