Back to resultsIncretin Effect on the Immunological Phenotype
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Liraglutide
Saxagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring autoimmune disease, diabetes type 1, incretin effect
Eligibility Criteria
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)
Sites / Locations
- Medical University Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liraglutide
Saxagliptin
Arm Description
Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.
Saxagliptin 5mg tablet by mouth every day for 4 weeks
Outcomes
Primary Outcome Measures
Increase of regulatory FOXP3+ T cells
the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks
Secondary Outcome Measures
Immunophenotyping
The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks
Full Information
NCT ID
NCT01782261
First Posted
January 30, 2013
Last Updated
October 10, 2016
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT01782261
Brief Title
Incretin Effect on the Immunological Phenotype
Official Title
Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes
Detailed Description
Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
autoimmune disease, diabetes type 1, incretin effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide
Arm Type
Experimental
Arm Description
Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.
Arm Title
Saxagliptin
Arm Type
Active Comparator
Arm Description
Saxagliptin 5mg tablet by mouth every day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
once daily subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
once daily tablet
Primary Outcome Measure Information:
Title
Increase of regulatory FOXP3+ T cells
Description
the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Immunophenotyping
Description
The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Pieber, Professor
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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Incretin Effect on the Immunological Phenotype
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