Incretin Effect on the Immunological Phenotype

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Saxagliptin; Drug: Liraglutide

• Registration Number: NCT01782261
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin	Saxagliptin	Saxagliptin 5mg tablet by mouth every day for 4 weeks
Liraglutide	Liraglutide	Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.

Primary Outcome Measures

Name	Time	Method
Increase of regulatory FOXP3+ T cells	4 weeks	the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Immunophenotyping	4 weeks	The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Austria