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Completed

NCT Number: NCT01782261

Incretin Effect on the Immunological Phenotype

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University Graz

Graz, 8036, Austria

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

liraglutide

Drug

once daily subcutaneous injection

Other names: Victoza

Saxagliptin

Drug

once daily tablet

Other names: Onglyza

Primary outcomes

  1. 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

Secondary outcomes

  1. Immunophenotyping

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2013
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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