A 4-month randomized controlled clinical trial of adjuvant exenatide or pramlintide versus insulin alone in pediatric type 1 diabetes mellitus: Effect on glycemic control
Sarah Elizabeth Withycombe
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This study investigates the effects of 16 weeks of treatment with adjuvant Exenatide or Pramlintide versus insulin alone on glycemic control, as measured by glycated hemoglobin (HbA1C) and 1,5-Anhydroglucitol (1,5-AG), or GlycoMark, in pediatric Type 1 Diabetes Mellitus (T1DM). We present here the preliminary results (n=24) of a Phase III randomized clinical trial designed to compare the glycemic effects of using adjuvant Pramlintide or Exenatide versus insulin alone in pediatric T1DM. Sample size calculations estimated 21 patients per treatment arm (63 total) are needed. So far, 24 patients have been recruited from Texas Children’s Hospital’s main Diabetes Care Center or its outlying clinics in the Houston, TX area. Recruited patients were randomized to one of 3 treatment arms (Pramlintide + insulin, Exenatide + insulin, or insulin alone) and completed 16 weeks of treatment. HbA1C and 1,5-AG levels were the primary endpoints analyzed as measures of glycemic control. All statistical analyses were\r\ndone using two-sample t-tests assuming equal variance and paired two-sample t-tests performed in Excel. No statistical differences in ΔHbA1C or Δ1,5-AG were observed between each treatment arm and the insulin control arm. Similarly, no statistical differences in HbA1C or 1,5-AG were reported within each group from baseline to 16 weeks. These preliminary data suggest that addition of Pramlintide or Exenatide to insulin regimen of pediatric T1DM does not improve glycemic control. However, reevaluation of the results upon study completion is warranted.