Pramlintide Lowered Glucose Excursions and Was Well-Tolerated in Adolescents with Type 1 Diabetes: Results from a Randomized, Single-Blind, Placebo-Controlled, Crossover Study. The Journal of pediatrics [J Pediatr] Journal article | | Title | Pramlintide Lowered Glucose Excursions and Was Well-Tolerated in Adolescents with Type 1 Diabetes: Results from a Randomized, Single-Blind, Placebo-Controlled, Crossover Study. | | Author(s) | Chase HP, Lutz K, Pencek R, Zhang B, Porter L | | Institution | Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, CO (H.P.C.) and Amylin Pharmaceuticals, Inc, San Diego, CA (K.L., R.P., B.Z., L.P.). | | Source | J Pediatr 2009 May 20. | | 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/m(2)) were randomized to pramlintide (15 or 30 mug) 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 (C(max)) (15-mug dose, 93 +/- 9 pg/mL; 30-mug dose, 202 +/- 21 pg/mL) occurred approximately 0.3 h (median time to peak concentration) after administration. Pramlintide reduced incremental area under the concentration curve (AUC(0-3h)) for glucagon and glucose versus placebo (glucagon: 15-mug dose, 4 +/- 7 pg *h/mL; 30-mug dose, 5 +/- 7 pg *h/mL; placebo, 35 +/- 9 pg *h/mL; glucose: 15-mug dose, 129 +/- 43 mg *h/dL; 30-mug dose, 132 +/- 37 mg *h/dL; placebo, 217 +/- 56 mg *h/dL). Acetaminophen C(max) decreased with pramlintide; median T(max) was delayed by approximately 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19464026 |
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