CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Intranasal glugagon +1 moredrug
Likely dose
Intranasal glugagon 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05206149
NCT05206149Phase 4Completed

Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes

A.O.U. Città della Salute e della Scienza·interventional·Posted Jan 25, 2022·Updated Jan 25, 2022

In Brief

A Phase 4 clinical trial evaluating Intranasal glugagon and Intranasal placebo for Hypopituitarism. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The diagnosis of secondary hypoadrenalism and GH deficiency (GHD) often requires the performance of a dynamic test. The glucagon stimulation test (GST) is one of the options for evaluating hypothalamic-pituitary function, representing a stimulus for both the corticotropic and somatotropic axis, substantially safe and easily available. The standard procedure involves the intramuscular injection of 1-1.5 mg of glucagon based on the patient's weight. In addition to its antero-pituitary function, glucagon has also shown its ability to stimulate neurohypophyseal secretion. Using the copeptin dosage, it has been shown that after the administration of glucagon in healthy subjects there is a significant release of ADH. However, the available data are scarse and there is no standardized protocol for the use of the glucagon test in diabetes insipidus. At the moment, GST is not the most frequently chosen diagnostic option. In fact, despite having the advantage of being able to investigate different areas of anterohypophyseal and probably posterohypophyseal function at the same time, the test has some disadvantages: the prolonged duration makes the procedure challenging, the intramuscular injection can be unwelcome, and many variables can come into play in the definition of a normal response (age, BMI, glycemic status). The recent introduction of a single-dose nasal powder formulation (Baqsimi®) could overcome some of the limitations of classic GST and make the procedure less demanding. To date, no assessments are yet available regarding a purely diagnostic role in the context of hypopituitarism of this new formulation. Through the knowledge of the physiological response of the adrenocortical, somatotropic and ADH axis to the administration of intranasal glucagon in healthy subjects, it will be possible to evaluate its possible application in the diagnosis of GH deficiency, central adrenal insufficiency and possibly diabetes insipidus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypopituitarism
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedJan 25, 2022
Enrollment StartOct 1, 2021
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.4 years ago

Interventions

Intranasal glugagondrug

Intranasal glucagon is administered at the dose of 3 mg. This corresponds to the administration of a single dose of Baqsimi®.

Intranasal placebodrug

Intranasal placebo (represented by isotonic saline solution) is administered.