Incretin Effect on the Immunological Phenotype

October 10, 2016 updated by: Medical University of Graz

Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects

Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.

Study Type

Interventional

Enrollment (Actual)

15

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

  • Austria
      • Graz, Austria, 8036
        • Medical University Graz

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 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-healthy subjects or patients with type 1 diabetes

Exclusion Criteria:

  • pregnancy
  • treatment with GLP-1-Analoga (Liraglutide, Exenatide)
  • treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)
  • chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide
Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.
Drug: Liraglutide
once daily subcutaneous injection
Other Names:
  • Victoza
Active Comparator: Saxagliptin
Saxagliptin 5mg tablet by mouth every day for 4 weeks
Drug: Saxagliptin
once daily tablet
Other Names:
  • Onglyza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of regulatory FOXP3+ T cells
Time Frame: 4 weeks
the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunophenotyping
Time Frame: 4 weeks
The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Thomas R Pieber, Professor, Medical University of Graz

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

February 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADPP004
  • 2011-006300-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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