drugset / Trial / NCT01201278

PK/PD Study of Intranasal Insulin in Type I Diabetes

NCT01201278

RandomizedCrossoverOpen-labelTreatment

Summary

This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated by means of the euglycemic glucose clamp technique.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 8 iu Intranasal
Subject Insulin Protein / enzyme biologic 16 iu Intranasal
Comparator Insulin Lispro Protein / enzyme biologic 8 iu Subcutaneous