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Incretin Effect on the Immunological Phenotype

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01782261
Enrollment
15
Registered
2013-02-01
Start date
2012-02-29
Completion date
2015-02-28
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

autoimmune disease, diabetes type 1, incretin effect

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.

Interventions

DRUGLiraglutide

once daily subcutaneous injection

DRUGSaxagliptin

once daily tablet

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Increase of regulatory FOXP3+ T cells4 weeksthe effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks

Secondary

MeasureTime frameDescription
Immunophenotyping4 weeksThe effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026