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

December 29, 2014 updated by: Profil Institut für Stoffwechselforschung GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Neuss, NRW, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Insulin lispro
Drug: Insulin LISPRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCINS.0-4h and AUCGIR.0-4h
Time Frame: 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.
up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

August 15, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (ESTIMATE)

August 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBC-14LIPOINJ01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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