Back to resultsThe Effect of Lixisenatide on the Effect of Pituitary Hormones
Primary Purpose
Healthy, Type 1 Diabetes
Status
Recruiting
Phase
Phase 4
Locations
Estonia
Study Type
Interventional
Intervention
Placebo
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy
Eligibility Criteria
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.
Sites / Locations
- Tartu University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Placebo, healthy volunteers
Lixisenatide 10 micrograms, healthy volunteers
Placebo, type 1 diabetic patients
Lixisenatide 10 micrograms, type 1 diabetic patients
Arm Description
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Growth hormone peak
Maximum growth hormone concentration measured after study drug administration.
Glucose nadir
Lowest glucose concentration measured after the study drug administration
C-peptide peak
Maximum c-peptide concentration measured after the study drug administration
Cortisol peak
Maximum cortisol concentration measured after the study drug administration
Adrenocorticotropic hormone (ACTH) peak
Maximum ACTH concentration measured after the study drug administration
Prolactin peak
Maximum prolactin concentration measured after the study drug administration
Copeptin peak
Maximum copeptin concentration measured after the study drug administration
Aldosterone peak
Maximum aldosterone concentration measured after the study drug administration
Full Information
NCT ID
NCT05804513
First Posted
March 27, 2023
Last Updated
June 9, 2023
Sponsor
University of Tartu
Collaborators
Tartu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05804513
Brief Title
The Effect of Lixisenatide on the Effect of Pituitary Hormones
Official Title
The Effect of Lixisenatide on the Effect of Pituitary Hormones
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tartu
Collaborators
Tartu University Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Type 1 Diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Blinded randomised two group crossover
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo, healthy volunteers
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Arm Title
Lixisenatide 10 micrograms, healthy volunteers
Arm Type
Active Comparator
Arm Description
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Arm Title
Placebo, type 1 diabetic patients
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Arm Title
Lixisenatide 10 micrograms, type 1 diabetic patients
Arm Type
Active Comparator
Arm Description
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium chloride 0.9% solution
Intervention Description
s/c injection
Intervention Type
Drug
Intervention Name(s)
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
Other Intervention Name(s)
Lyxumia
Intervention Description
s/c injection
Primary Outcome Measure Information:
Title
Growth hormone area under the curve.
Description
Treatment effect (placebo vs lixisenatide) on growth hormone area under curve (AUC) is compared between patients with type 1 diabetes and healthy volunteers.
Time Frame
0-150 minutes after study drug administration
Secondary Outcome Measure Information:
Title
Growth hormone peak
Description
Maximum growth hormone concentration measured after study drug administration.
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration.
Title
Glucose nadir
Description
Lowest glucose concentration measured after the study drug administration
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
C-peptide peak
Description
Maximum c-peptide concentration measured after the study drug administration
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
Cortisol peak
Description
Maximum cortisol concentration measured after the study drug administration
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
Adrenocorticotropic hormone (ACTH) peak
Description
Maximum ACTH concentration measured after the study drug administration
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
Prolactin peak
Description
Maximum prolactin concentration measured after the study drug administration
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
Copeptin peak
Description
Maximum copeptin concentration measured after the study drug administration
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
Aldosterone peak
Description
Maximum aldosterone concentration measured after the study drug administration
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Other Pre-specified Outcome Measures:
Title
Nausea
Description
The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea.
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
Systolic and diastolic blood pressure
Description
The change in systolic and diastolic blood pressure compared to baseline.
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration
Title
Heart rate
Description
The change in heart rate compared to baseline.
Time Frame
30, 60, 90, 120, and 150 minutes after the study drug administration.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vallo Volke, MD, PhD
Phone
7374330
Ext
+372
Email
vallo.volke@ut.ee
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Reppo, MD
Phone
53318642
Ext
+372
Email
ingrid.reppo@kliinikum.ee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vallo Volke, MD, PhD
Organizational Affiliation
University of Tartu, Tartu University Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Reppo
Phone
53318642
Ext
+372
Email
ingrid.reppo@kliinikum.ee
First Name & Middle Initial & Last Name & Degree
Vallo Volke
Email
vallo.volke@ut.ee
12. IPD Sharing Statement
Learn more about this trial
The Effect of Lixisenatide on the Effect of Pituitary Hormones
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