drugset / Trial / NCT02221323

A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1

NCT02221323

Phase 2 Completed 18 enrolled Profil Institute for Metabolic Research GmbH
RandomizedSingle-groupOpen-labelBasic science

Summary

The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin efficacy after injection into these different areas is still unclear. The results from this study may expand the knowledge on the severity of this issue and may provide evidence for future treatment recommendations regarding injection sites for insulin administration.

Timeline

Start
2014-09
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Lispro Protein / enzyme biologic Subcutaneous

Indications