The Effect of Lixisenatide on the Effect of Pituitary Hormones

NCTNCT05804513Other idLixi22

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 10 participants (estimated)
Sponsor: University of Tartu · Other
Design: Randomized · Single masking
Countries: 1 country
Estonia
Start: 17 Apr 2023
Primary completion: 31 Oct 2023 (estimated)
Completion: 31 Dec 2023 (estimated)
First posted: 7 Apr 2023
Last update posted: 12 Jun 2023
Conditions: Healthy · Type 1 Diabetes

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024

Ph 4
The Effect of Lixisenatide on the Effect of Pituitary Hormones
NCT05804513
17 Apr 2023 to est. 31 Dec 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The current study has two aims: 1. to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test; 2. to test if the growth hormone-stimulating effect is mediated by changes in blood glucose. The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).

Interventions

PlaceboDrug
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen InjectorDrug

Arms4

Placebo comparator
Placebo, healthy volunteers
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Active comparator
Lixisenatide 10 micrograms, healthy volunteers
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Placebo comparator
Placebo, type 1 diabetic patients
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Active comparator
Lixisenatide 10 micrograms, type 1 diabetic patients
Lixisenatide 10 micrograms. Subcutaneous injection administered once.

Primary outcomes1

Outcomes the sponsor listed as primary.

Growth hormone area under the curve.
Time frame · 0-150 minutes after study drug administration
Registry description
Treatment effect (placebo vs lixisenatide) on growth hormone area under curve (AUC) is compared between patients with type 1 diabetes and healthy volunteers.

Secondary outcomes(8)

Growth hormone peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration.
Registry description
Maximum growth hormone concentration measured after study drug administration.
Glucose nadir
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Registry description
Lowest glucose concentration measured after the study drug administration
C-peptide peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Registry description
Maximum c-peptide concentration measured after the study drug administration
Cortisol peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Registry description
Maximum cortisol concentration measured after the study drug administration
Adrenocorticotropic hormone (ACTH) peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Registry description
Maximum ACTH concentration measured after the study drug administration
Prolactin peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Registry description
Maximum prolactin concentration measured after the study drug administration
Copeptin peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Registry description
Maximum copeptin concentration measured after the study drug administration
Aldosterone peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Registry description
Maximum aldosterone concentration measured after the study drug administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Healthy volunteers: * male sex * age 18-60 years * body weight \> 65 kg 2. Patients with type 1 diabetes: * type 1 diabetes * male sex * age 18-60 years * body weight \> 65 kg * c-peptide in fasting blood sample \<0,1 nmol/l * HbA1c \< 8,5% Exclusion Criteria: 1. Healthy volunteers: * use of aldosterone antagonist * use of glucocorticosteroid * use of other medication that potentially significantly affects pituitary function. 2. Patients with type 1 diabetes: * use of aldosterone antagonist * use of glucocorticosteroid * use of other medication that potentially significantly affects pituitary function. * The patient is excluded from the study if a significant change in blood glucose occurs in the study center.

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