Properties of pramlintide and insulin upon mixing

Autor: Mario F. Sylvestri, Susan Strobel, Mark Fineman, Christian Weyer, Joann Data, Orville G. Kolterman, Larry Z. Shen
Rok vydání: 2005
Předmět:
Zdroj: American Journal of Health-System Pharmacy. 62:816-822
ISSN: 1535-2900
1079-2082
Popis: Purpose. The pharmacokinetics, pharmacodynamics, and safety of pramlintide and various insulin formulations in patients with type 1 diabetes mellitus (DM) when given as separate injections or mixed in the same syringe before injection were studied. Methods. In two randomized, open-label, placebo-controlled, five-period-crossover studies, patients with type 1 DM received preprandial injections of pramlintide, short-acting insulin, and long-acting insulin administered either by separate injections or after mixing in various combinations. Serum free insulin and plasma glucose concentrations were measured for 10 hours and plasma pramlintide concentrations for 5 hours after injection. Results. Blood samples were collected from a total of 51 patients. All treatments involving mixtures were comparable to separate injections with respect to the area under the concentration-versus-time curve (AUC) and the maximum concentration ( C max) of serum free insulin. There were some minor differences in the AUC and C max of pramlintide. No injection-site reactions or other unexpected adverse events were observed. Conclusion. Mixing pramlintide with short- or long-acting insulin in the same syringe before subcutaneous injection did not affect the pharmacodynamics of glucose or the pharmacokinetics of insulin or pramlintide in a clinically significant manner.
Databáze: OpenAIRE