Effect of exenatide on cortisol secretion

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001437-12-EE

Enrollment

Registered

2017-04-13

Start date

2017-06-12

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: Not applicable;Primary end point(s): Maximum level of cortisol after single exenatide injection;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.	—

Measure

Time frame

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.;Secondary Objective: Not applicable;Primary end point(s): Maximum level of cortisol after single exenatide injection;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.

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Secondary

Measure	Time frame
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).;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.	—

Measure

Time frame

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).;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.

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Countries

Estonia

Contacts

Public ContactDepartment of Physiology

University of Tartu

vallo.volke@ut.ee

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026