ClinicalTrials.gg
CompletedNCT05206149Updated Jan 25, 2022

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

A Phase 4 interventional study of Intranasal glugagon and Intranasal placebo in Hypopituitarism, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by A.O.U. Città della Salute e della Scienza · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypopituitarism

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03

In context

Hypopituitarism

47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.

This study's enrollment of 10 is below the median of 38 across 29 interventional studies indexed under Hypopituitarism.

Browse Hypopituitarism studies →

Lead sponsor

A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any adult healthy subject (age >= 18 years old) and not meeting the exclusion criteria listed below

Exclusion criteria

Exclusion Criteria:

  • \< 18.5 kg/m2 or > 25 kg/m2
  • Any active pharmacological treatment
  • Pregnancy or breastfeeding
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Intranasal Administration of Glucagon

    Intranasal administration of glucagon in healthy subjects

    Drug: Intranasal glugagon

  • Placebo comparator
    Intranasal Administration of Placebo

    Intranasal administration of placebo (isotonic saline solution) in healthy subjects

    Drug: Intranasal placebo

Interventions

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

    Also known as: Baqsimi®

  • DrugIntranasal placebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  2. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  3. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  4. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  5. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  6. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  7. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  8. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  9. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  10. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  11. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  12. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  13. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  14. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  15. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  16. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  17. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  18. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  19. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  20. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  21. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  22. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  23. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  24. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  25. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  26. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  27. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  28. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  29. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  30. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  31. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  32. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  33. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  34. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  35. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  36. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

Secondary outcomes

  1. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  2. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  3. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  4. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  5. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  6. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  7. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  8. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  9. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  10. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  11. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  12. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  13. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  14. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  15. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  16. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  17. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  18. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  19. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  20. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  21. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  22. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  23. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  24. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  25. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  26. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  27. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  28. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  29. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  30. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  31. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  32. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  33. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  34. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  35. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  36. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  37. 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.

    Time frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration

  38. 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.

    Time frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration

  39. 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.

    Time frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration

  40. 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.

    Time frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration

  41. 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.

    Time frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration

  42. 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.

    Time frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration

  43. 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.

    Time frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration

  44. 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.

    Time frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration

  45. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  46. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  47. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  48. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  49. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  50. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  51. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

  52. 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.

    Time frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

07

Study locations

1 site
  • AOU Città della Salute e della Scienza
    Torino, Piemonte 10126, Italy
08

References and documents

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 28646378 ↗
  • Arvat 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 11078983 ↗
  • Berg 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 19996199 ↗
  • Yuen 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 22806554 ↗
  • Giuffrida 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 18678516 ↗
  • Dichtel 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 25210883 ↗
  • Hamrahian 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 26897383 ↗
  • Lewandowski 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 26578365 ↗
  • Guzman 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 29053231 ↗
  • Sherr 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05206149
Lead sponsor
A.O.U. Città della Salute e della Scienza
Responsible party
Ezio Ghigo (Full Professor, A.O.U. Città della Salute e della Scienza) — Principal investigator
First posted
Jan 25, 2022
Start date
Oct 1, 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jan 25, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Glucagon

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