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NCT02221323 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
A Trial to Compare the Pharmacokinetics and Pharmacodynamics of Insulin Lispro Administered s.c. Into Lipohypertrophic or Normal Abdominal Adipose Tissue in Subjects With Diabetes Mellitus Type 1

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02221323
Other study ID # DBC-14LIPOINJ01
Secondary ID
Status Completed
Phase Phase 2
First received August 15, 2014
Last updated December 29, 2014
Start date September 2014
Est. completion date November 2014

Study information
Verified date December 2014
Source Profil Institut für Stoffwechselforschung GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

Exclusion Criteria:

- 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin LISPRO

Locations
Country Name City State
Germany Profil Institut für Stoffwechselforschung GmbH Neuss NRW

Sponsors (1)
Lead Sponsor Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCINS.0-4h and AUCGIR.0-4h 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.		 up to 4 hours No
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