HypopituitarismPhase 4NCT05206149
Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes
A Phase 4 study testing Intranasal glugagon in people with Hypopituitarism, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypopituitarism
- What is being tested?
- Intranasal glugagon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 31 Dec 2021
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult healthy subject (age >= 18 years old) and not meeting the exclusion criteria listed below
Who cannot join
- BMI < 18.5 kg/m2 or > 25 kg/m2
- Any active pharmacological treatment
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hypopituitarism
- Being tested
- Intranasal glugagon, Intranasal placebo
- Medical subject headings
- Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal glugagonDrug
Also called Baqsimi®
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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Administration of Glucagon | Experimental | Intranasal administration of glucagon in healthy subjects Receives: Drug: Intranasal glugagon |
| Intranasal Administration of Placebo | Placebo comparator | Intranasal administration of placebo (isotonic saline solution) in healthy subjects Receives: Drug: Intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ACTH levels between baseline and 15 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 30 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 45 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 60 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 75 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 90 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 120 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 150 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in serum ACTH levels between baseline and 180 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 15 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 30 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 45 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 60 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 75 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 90 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 120 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 150 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in serum cortisol levels between baseline and 180 minutes after glucagon/placebo administration
The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 15 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 30 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 45 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 60 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 75 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 90 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 120 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 150 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in serum GH levels between baseline and 180 minutes after glucagon/placebo administration
The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 15 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 30 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 45 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 60 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 75 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 90 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 120 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 150 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in plasma copeptin levels between baseline and 180 minutes after glucagon/placebo administration
The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Secondary outcomes (52)
Change in serum sodium levels between baseline and 15 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 30 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 45 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 60 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 75 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 90 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 120 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 150 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in serum sodium levels between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 15 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 30 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 45 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 60 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 75 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 90 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 120 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 150 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in serum potassium levels between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 15 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 30 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 45 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 60 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 75 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 90 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 120 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 150 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in plasma osmolality between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 15 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 30 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 45 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 60 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 75 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 90 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 120 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 150 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in serum glucose levels between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 15 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 30 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 45 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 60 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 75 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 90 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 120 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 150 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Change in plasma insulin levels between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in urine sodium levels between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine sodium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in urine potassium levels between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine potassium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in urine creatinine levels between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine creatinine (mg/dl) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in urine osmolality between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine osmolality (mOsm/kg) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in resistance at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring resistance (Ohm) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in reactance at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring reactance (Ohm) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Change in phase angle at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration
The response to the administration of intranasal glucagon, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring phase angle (°) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.
Measured: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypopituitarismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezio Ghigo, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206149
- Sponsor's protocol ID
- GST-intranasale
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boguszewski CL. Glucagon stimulation test: has its time come? Endocrine. 2017 Sep;57(3):361-363. doi: 10.1007/s12020-017-1356-8. Epub 2017 Jun 23. No abstract available.
PubMed 28646378Arvat E, Maccagno B, Ramunni J, Giordano R, Broglio F, Gianotti L, Maccario M, Camanni F, Ghigo E. Interaction between glucagon and hexarelin, a peptidyl GH secretagogue, on somatotroph and corticotroph secretion in humans. Eur J Endocrinol. 2000 Nov;143(5):601-6. doi: 10.1530/eje.0.1430601.
PubMed 11078983Berg C, Meinel T, Lahner H, Yuece A, Mann K, Petersenn S. Diagnostic utility of the glucagon stimulation test in comparison to the insulin tolerance test in patients following pituitary surgery. Eur J Endocrinol. 2010 Mar;162(3):477-82. doi: 10.1530/EJE-09-0824. Epub 2009 Dec 8.
PubMed 19996199Yuen KC, Biller BM, Katznelson L, Rhoads SA, Gurel MH, Chu O, Corazzini V, Spiller K, Gordon MB, Salvatori R, Cook DM. Clinical characteristics, timing of peak responses and safety aspects of two dosing regimens of the glucagon stimulation test in evaluating growth hormone and cortisol secretion in adults. Pituitary. 2013 Jun;16(2):220-30. doi: 10.1007/s11102-012-0407-7.
PubMed 22806554Giuffrida FM, Berger K, Monte L, Oliveira CH, Hoff AO, Maciel RM, Vieira JG. Relationship between GH response and glycemic fluctuations in the glucagon stimulation test. Growth Horm IGF Res. 2009 Feb;19(1):77-81. doi: 10.1016/j.ghir.2008.06.002. Epub 2008 Aug 3.
PubMed 18678516Dichtel LE, Yuen KC, Bredella MA, Gerweck AV, Russell BM, Riccio AD, Gurel MH, Sluss PM, Biller BM, Miller KK. Overweight/Obese adults with pituitary disorders require lower peak growth hormone cutoff values on glucagon stimulation testing to avoid overdiagnosis of growth hormone deficiency. J Clin Endocrinol Metab. 2014 Dec;99(12):4712-9. doi: 10.1210/jc.2014-2830.
PubMed 25210883Hamrahian AH, Yuen KC, Gordon MB, Pulaski-Liebert KJ, Bena J, Biller BM. Revised GH and cortisol cut-points for the glucagon stimulation test in the evaluation of GH and hypothalamic-pituitary-adrenal axes in adults: results from a prospective randomized multicenter study. Pituitary. 2016 Jun;19(3):332-41. doi: 10.1007/s11102-016-0712-7.
PubMed 26897383Lewandowski KC, Lewinski A, Skowronska-Jozwiak E, Stasiak M, Horzelski W, Brabant G. Copeptin under glucagon stimulation. Endocrine. 2016 May;52(2):344-51. doi: 10.1007/s12020-015-0783-7. Epub 2015 Nov 17.
PubMed 26578365Guzman CB, Dulude H, Piche C, Rufiange M, Sadoune AA, Rampakakis E, Carballo D, Triest M, Zhang MX, Zhang S, Tafreshi M, Sicard E. Effects of common cold and concomitant administration of nasal decongestant on the pharmacokinetics and pharmacodynamics of nasal glucagon in otherwise healthy participants: A randomized clinical trial. Diabetes Obes Metab. 2018 Mar;20(3):646-653. doi: 10.1111/dom.13134. Epub 2017 Nov 19.
PubMed 29053231Sherr JL, Ruedy KJ, Foster NC, Piche CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW; T1D Exchange Intranasal Glucagon Investigators. Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):555-62. doi: 10.2337/dc15-1606. Epub 2016 Feb 16.
PubMed 26884472