The Effect of Lixisenatide on the Effect of Pituitary Hormones

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

Detailed Description
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The randomized, blinded, placebo-controlled clinical trial is conducted on 5 healthy volunteers and 5 patients with type 1 diabetes. All study subjects receive once a placebo and once 10 micrograms of lixisenatide. The order of administration of study medication is decided on randomization. The placebo and lixisenatide are administered at least 2 days apart. Blood samples are taken 30 minutes and immediately before study medication administration and 30, 60, 90, 120, and 150 minutes after study medication administration,. The primary endpoint is the peak value of growth hormone measured during the 2,5 hours after study medication administration.

Official Title
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The Effect of Lixisenatide on the Effect of Pituitary Hormones

Conditions
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Type 1 Diabetes, Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Blinded randomised two group crossover
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo, healthy volunteers<br>Sodium chloride 0.9% solution. Subcutaneous injection administered once. | Drug: Placebo<br>* s/c injection<br>* Other names: Sodium chloride 0.9% solution;|
| Active Comparator: Lixisenatide 10 micrograms, healthy volunteers<br>Lixisenatide 10 micrograms. Subcutaneous injection administered once. | Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector<br>* s/c injection<br>* Other names: Lyxumia;|
| Placebo Comparator: Placebo, type 1 diabetic patients<br>Sodium chloride 0.9% solution. Subcutaneous injection administered once. | Drug: Placebo<br>* s/c injection<br>* Other names: Sodium chloride 0.9% solution;|
| Active Comparator: Lixisenatide 10 micrograms, type 1 diabetic patients<br>Lixisenatide 10 micrograms. Subcutaneous injection administered once. | Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector<br>* s/c injection<br>* Other names: Lyxumia;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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