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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221323
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Insulin LISPRO Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin lispro Drug: Insulin LISPRO



Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221323


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, NRW, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Investigators
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Principal Investigator: Ulrike Hövelmann Profil Institut für Stoffwechselforschung GmbH
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Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT02221323    
Other Study ID Numbers: DBC-14LIPOINJ01
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs