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CHRISTIAN WEYER, M.D., is Senior Director, Clinical Research; MARK S. FINEMAN, B.S., is Senior Director, Clinical Affairs; Susan STROBEL, PH.D., is Senior Medical Writer; LARRY SHEN, PH.D., is Senior Director, Biometrics; JOANN DATA, M.D., PH.D., is Senior Vice President, Regulatory Affairs and Quality Assurance; ORVILLE G. KOLTERMAN, M.D., is Senior Vice President, Clinical Affairs; and MARIO F. SYLVESTRI, PHARM.D., PH.D., is Senior Director, Regulatory and Medical Information, Amylin Pharmaceuticals, Inc., San Diego, CA.

Address correspondence to Dr. Sylvestri at Amylin Pharmaceuticals, Inc., 9360 Towne Centre Drive, San Diego, CA 92121 (msylvestri{at}amylin.com).

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 (Cmax) of serum free insulin. There were some minor differences in the AUC and Cmax 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. Index terms: Antidiabetic agents; Blood levels; Diabetes mellitus; Drug interactions; Incompatibilities; Injections; Insulins; Pharmacodynamics; Pharmacokinetics; Pramlintide acetate; Stability; Toxicity

 

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