NCT01782261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

January 30, 2013

Last Update Submit

October 10, 2016

Conditions

Type 1 Diabetes

Keywords

autoimmune diseasediabetes type 1incretin effect

Outcome Measures

Primary Outcomes (1)

  • Increase of regulatory FOXP3+ T cells

    the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks

    4 weeks

Secondary Outcomes (1)

  • Immunophenotyping

    4 weeks

Study Arms (2)

Liraglutide

EXPERIMENTAL

Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.

Drug: Liraglutide

Saxagliptin

ACTIVE COMPARATOR

Saxagliptin 5mg tablet by mouth every day for 4 weeks

Drug: Saxagliptin

Interventions

LiraglutideDRUG

once daily subcutaneous injection

Also known as: Victoza
Liraglutide
SaxagliptinDRUG

once daily tablet

Also known as: Onglyza
Saxagliptin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects or patients with type 1 diabetes

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Autoimmune Diseases

Interventions

Liraglutidesaxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Thomas R Pieber, Professor

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 1, 2013

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 11, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)