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

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Title: 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
Author: Sarah Elizabeth Withycombe
Abstract: 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 & #916 ;HbA1C or & #916 ;1 ,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 .
URI: http : / /hdl .handle .net /2152 .3 /197
Date: 2010-07-29

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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. The University of Texas Medical Branch. Available electronically from http : / /hdl .handle .net /2152 .3 /197 .

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