Incretin Effect on the Immunological Phenotype

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01782261
First received: January 30, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 2014
Estimated Primary Completion Date: September 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782261

Contacts
Contact: Gerlies Treiber, MD +43/316/38512383 gerlies.treiber@medunigraz.at
Contact: Silvia Leitgeb, Bcs +43/316/38512383 silvia.leitgeb@medunigraz.at

Locations
Austria
Medical University Graz Recruiting
Graz, Austria, 8036
Principal Investigator: Thomas Pieber, Prof.         
Sub-Investigator: Gerlies Treiber, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R Pieber, Professor Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01782261     History of Changes
Other Study ID Numbers: ADPP004, 2011-006300-12
Study First Received: January 30, 2013
Last Updated: April 3, 2014
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:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Incretins
Liraglutide
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014