Effect of exenatide on cortisol secretion

• Register: EUCTR
• Last refreshed on: 3 July 2017
• Main ID: EUCTR2017-001437-12-EE
• Date of registration: 13/04/2017
• Prospective Registration: Yes
• Primary sponsor: University of Tartu
• Public title: Effect of exenatide on cortisol secretion
• Scientific title: Effect of exenatide on cortisol secretion
• Date of first enrolment: 12/06/2017
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001437-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Estonia

Contacts

• Name: Department of Physiology
• Affiliation: University of Tartu

• Name: Department of Physiology
• Affiliation: University of Tartu

Key inclusion & exclusion criteria

Inclusion criteria:
1) Age 18-50 years
2) Bodyweight >65 kg
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Existence of chronic disease
2) Existence of drugs used daily
3) Pregnancy, lactation
4) Use of oral contraceptives during two month before the study


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

Health Condition(s) or Problem(s) studied

Healthy volunteers

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Trade Name: Byetta
Product Name: Byetta
Pharmaceutical Form: Solution for injection in pre-filled pen

Primary Outcome(s)

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: The blood samples for measuring cortisol level are taken before the exenatide injection and 30, 60, 90 and 120 minutes after the administration.

Main Objective: The main objective is to test whether exenatide (10 micrograms s.c) stimulates ACTH /cortisol release and what is the magnitude of cortisol response in healthy volunteers. If the response is comparabele to the responses reported during glucagon stimulation test, there is a potential to use the drug to test for secondary adrenal insufficiency.

Primary end point(s): Maximum level of cortisol after single exenatide injection

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The blood samples for measuring hormonal and biochemical markers are taken and blood pressure and heart rate are measured before the exenatide injection and 30, 60, 90 and 120 minutes after the administration.

Secondary end point(s): Levels of other related hormonal and biochemical markers and changes in heart rate and blood pressure after exenatide single administration (incl. glucose, ACTH).

Secondary ID(s)

Ex17

Source(s) of Monetary Support

University of Tartu