The Effect of Lixisenatide on the Effect of Pituitary Hormones

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).

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vallo Volke, MD, PhD; Phone Number: +372 7374330; Email: vallo.volke@ut.ee
• Study Contact Backup: Name: Ingrid Reppo, MD; Phone Number: +372 53318642; Email: ingrid.reppo@kliinikum.ee

Study Locations

• Estonia
  • Tartu, Estonia, 50406
    • Recruiting
    • Tartu University Hospital
    • Contact: Ingrid Reppo; Phone Number: +372 53318642; Email: ingrid.reppo@kliinikum.ee
    • Contact: Vallo Volke; Email: vallo.volke@ut.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea.	30, 60, 90, 120, and 150 minutes after the study drug administration
Systolic and diastolic blood pressure	The change in systolic and diastolic blood pressure compared to baseline.	30, 60, 90, 120, and 150 minutes after the study drug administration
Heart rate	The change in heart rate compared to baseline.	30, 60, 90, 120, and 150 minutes after the study drug administration.

Collaborators and Investigators

• Sponsor: University of Tartu
• Collaborators: Tartu University Hospital
• Investigators: Principal Investigator: Vallo Volke, MD, PhD, University of Tartu, Tartu University Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypothalamic Diseases; Diabetes Mellitus, Type 1; Pituitary Diseases; Hypoglycemic Agents; Physiological Effects of Drugs; Lixisenatide
• Other Study ID Numbers: Lixi22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No