Properties of pramlintide and insulin upon mixing.

Abstract

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.

• Authors: Christian Weyer, Mark S Fineman, Susan Strobel, Larry Shen, Joann Data, Orville G Kolterman, Mario F Sylvestri
• Journal: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists (Am J Health Syst Pharm) Vol. 62 Issue 8 Pg. 816-22 (Apr 15 2005) ISSN: 1079-2082 [Print] England
• PMID: 15821274 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Amyloid
• Drug Combinations
• Insulin
• Islet Amyloid Polypeptide
• Placebos
• pramlintide

Topics

• Adolescent
• Adult
• Aged
• Amyloid (administration & dosage, adverse effects, pharmacokinetics)
• Area Under Curve
• Cross-Over Studies
• Diabetes Mellitus, Type 1 (drug therapy)
• Drug Combinations
• Female
• Humans
• Insulin (administration & dosage, adverse effects, pharmacokinetics)
• Islet Amyloid Polypeptide
• Male
• Middle Aged
• Placebos
• United States