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Incretin Effect on the Immunological Phenotype

This study has been completed.
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: January 30, 2013
Last updated: October 10, 2016
Last verified: October 2016
Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

Condition Intervention Phase
Type 1 Diabetes
Drug: Liraglutide
Drug: Saxagliptin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects

Resource links provided by NLM:

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Immunophenotyping [ Time Frame: 4 weeks ]
    The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks

Enrollment: 15
Study Start Date: February 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide
Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.
Drug: Liraglutide
once daily subcutaneous injection
Other Name: Victoza
Active Comparator: Saxagliptin
Saxagliptin 5mg tablet by mouth every day for 4 weeks
Drug: Saxagliptin
once daily tablet
Other Name: Onglyza

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01782261

Medical University Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Thomas R Pieber, Professor Medical University of Graz
  More Information

Responsible Party: Medical University of Graz Identifier: NCT01782261     History of Changes
Other Study ID Numbers: ADPP004
2011-006300-12 ( EudraCT Number )
Study First Received: January 30, 2013
Last Updated: October 10, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Medical University of Graz:
autoimmune disease
diabetes type 1
incretin effect

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents processed this record on May 25, 2017