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