Pilot study of the incretin effect on the immunological phenotype in healthy subjects and subjects with type 1 diabetes: Step 4 of the Austrian Diabetes Prevention Programme (ADPP-004).

• Register: EUCTR
• Last refreshed on: 21 May 2018
• Main ID: EUCTR2011-006300-12-AT
• Date of registration: 24/01/2012
• Prospective Registration: Yes
• Primary sponsor: Medizinische Universität Graz, Kl. Abteilung für Endokrinologie und Stoffwechsel
• Public title: Pilot study of the incretin effect on the immunological phenotype in healthy subjects and subjects with type 1 diabetes: Step 4 of the Austrian Diabetes Prevention Programme (ADPP-004).
• Scientific title: Pilot study of the incretin effect on the immunological phenotype in healthy subjects and subjects with type 1 diabetes: Step 4 of the Austrian Diabetes Prevention Programme (ADPP-004).
• Date of first enrolment: 23/02/2012
• Target sample size: 32
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006300-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria

Contacts

• Name: Klin.Abt. f. Endokrin. u. Stoffw.
• Affiliation: Medizinische Universität Graz

• Name: Klin.Abt. f. Endokrin. u. Stoffw.
• Affiliation: Medizinische Universität Graz

Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

healthy volunteers

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Trade Name: Victoza
Product Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Other descriptive name: GLP-1 Analogon
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Trade Name: Onglyza
Product Name: Onglyza
Pharmaceutical Form: Tablet
CAS Number: 709031-78-7
Other descriptive name: SAXAGLIPTIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective:

Primary end point(s):

Main Objective:

Secondary ID(s)

ADPP-004

Source(s) of Monetary Support

EASD