A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
- Registration Number
- NCT02221323
- Lead Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- AUCINS.0-4h and AUCGIR.0-4h during treatment period 1
- AUCINS.0-4h and AUCBG.0-4h during treatment period 2, intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin lispro Insulin LISPRO -
- Primary Outcome Measures
Name Time Method AUCINS.0-4h and AUCGIR.0-4h up to 4 hours Compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c.
administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, NRW, Germany