Incretin Effect on the Immunological Phenotype

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: January 30, 2013
Last updated: April 16, 2015
Last verified: April 2015
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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks

Estimated Enrollment: 32
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 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
Genders Eligible for Study:   Both
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)
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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

No publications provided

Responsible Party: Medical University of Graz Identifier: NCT01782261     History of Changes
Other Study ID Numbers: ADPP004, 2011-006300-12
Study First Received: January 30, 2013
Last Updated: April 16, 2015
Health Authority: Austria: Federal Office for Safety in Health Care

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

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors processed this record on November 30, 2015