The Effect of Lixisenatide on the Effect of Pituitary Hormones

Phase 4

Recruiting

• Conditions: Healthy; Type 1 Diabetes
• Interventions: Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector; Drug: Placebo

• Registration Number: NCT05804513
• Lead Sponsor: University of Tartu

Brief Summary

The current study has two aims:

1. to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test;

2. to test if the growth hormone-stimulating effect is mediated by changes in blood glucose.

The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-07
• Study Start: 2023-04-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

1. Healthy volunteers:

   • male sex
   • age 18-60 years
   • body weight > 65 kg

2. Patients with type 1 diabetes:

   • type 1 diabetes
   • male sex
   • age 18-60 years
   • body weight > 65 kg
   • c-peptide in fasting blood sample <0,1 nmol/l
   • HbA1c < 8,5%

Exclusion Criteria

1. Healthy volunteers:

   • use of aldosterone antagonist
   • use of glucocorticosteroid
   • use of other medication that potentially significantly affects pituitary function.

2. Patients with type 1 diabetes:

   • use of aldosterone antagonist
   • use of glucocorticosteroid
   • use of other medication that potentially significantly affects pituitary function.
   • The patient is excluded from the study if a significant change in blood glucose occurs in the study center.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lixisenatide 10 micrograms, healthy volunteers	Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector	Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Lixisenatide 10 micrograms, type 1 diabetic patients	Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector	Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Placebo, healthy volunteers	Placebo	Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Placebo, type 1 diabetic patients	Placebo	Sodium chloride 0.9% solution. Subcutaneous injection administered once.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia