Pramlintide Lowered Glucose Excursions and Was Well-Tolerated in Adolescents with Type 1 Diabetes: Results from a Randomized, Single-Blind, Placebo-Controlled, Crossover Study - 09/08/11
, Karen Lutz, PhD b, Richard Pencek, PhD b, Bei Zhang, MD b, Lisa Porter, MD b
Reprint requests: H. Peter Chase, MD, Professor of Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, PO Box 6511, 1775 Aurora Ct, Rm 1304, Aurora, CO 80045-6511.Abstract |
Objectives |
To evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of pramlintide in treating adolescents with type 1 diabetes.
Study design |
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m2) were randomized to pramlintide (15 or 30 μg) or placebo administered before a standardized breakfast. Insulin lispro (50% of usual mealtime dose) was injected separately. Acetaminophen (1000 mg) was administered orally to provide an indicator of gastric emptying rate.
Results |
In 9 evaluable subjects, plasma pramlintide concentrations increased dose-proportionately; mean peak plasma concentration (Cmax) (15-μg dose, 93 ± 9 pg/mL; 30-μg dose, 202 ± 21 pg/mL) occurred 
0.3 h (median time to peak concentration) after administration. Pramlintide reduced incremental area under the concentration curve (AUC0-3h) for glucagon and glucose versus placebo (glucagon: 15-μg dose, 4 ± 7 pgh/mL; 30-μg dose, 5 ± 7 pgh/mL; placebo, 35 ± 9 pgh/mL; glucose: 15-μg dose, 129 ± 43 mgh/dL; 30-μg dose, 132 ± 37 mgh/dL; placebo, 217 ± 56 mgh/dL). Acetaminophen Cmax decreased with pramlintide; median Tmax was delayed by 2.6- to 3.8-fold. Pramlintide was well tolerated, and no treatment-related adverse events occurred.
Conclusions |
Pramlintide reduced postprandial glucagon and glucose excursions and slowed gastric emptying in adolescents with type 1 diabetes, with no treatment-related adverse events. Long-term studies evaluating the efficacy and safety of pramlintide in adolescents are warranted.
Le texte complet de cet article est disponible en PDF.Mots-clés : AUC, Cmax, CI, CV, CL/F, DCCT, GLP-1, LS, SE, t1/2, Tmax, V/F
Plan
| H.P.C. has received research funding from Amylin Pharmaceuticals, Inc. K.L., R.P., B.Z., and L.P. are all employees and stockholders of Amylin Pharmaceuticals, Inc. |
Vol 155 - N° 3
P. 369-373 - septembre 2009 Retour au numéro
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