Incretin Effect on the Immunological Phenotype

This study is currently recruiting participants.
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
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
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Incretins
Saxagliptin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 17, 2014