Back to resultsA Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Insulin LISPRO
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Profil Institut für Stoffwechselforschung GmbH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Insulin lispro
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02221323
First Posted
August 15, 2014
Last Updated
December 29, 2014
Sponsor
Profil Institut für Stoffwechselforschung GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02221323
Brief Title
A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Profil Institut für Stoffwechselforschung GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin lispro
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Primary Outcome Measure Information:
Title
AUCINS.0-4h and AUCGIR.0-4h
Description
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.
Time Frame
up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Hövelmann
Organizational Affiliation
Profil Institut für Stoffwechselforschung GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
State/Province
NRW
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
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