Incretin Effect on the Immunological Phenotype

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782261
• Other study ID #: ADPP004
• Secondary ID: 2011-006300-12
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2013
• Last updated: October 10, 2016
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: October 2016
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Liraglutide
once daily subcutaneous injection
• Saxagliptin
once daily tablet

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks	No
Secondary	Immunophenotyping	The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks	4 weeks	No