The Effect of Lixisenatide on the Effect of Pituitary Hormones
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo, healthy volunteers Sodium chloride 0.9% solution. Subcutaneous injection administered once. |
Drug: Placebo
s/c injection
Other Names:
|
| 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:
|
| Placebo Comparator: Placebo, type 1 diabetic patients Sodium chloride 0.9% solution. Subcutaneous injection administered once. |
Drug: Placebo
s/c injection
Other Names:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Cortisol peak [30, 60, 90, 120, and 150 minutes after the study drug administration]
Maximum cortisol 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
- Prolactin peak [30, 60, 90, 120, and 150 minutes after the study drug administration]
Maximum prolactin 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
- Aldosterone peak [30, 60, 90, 120, and 150 minutes after the study drug administration]
Maximum aldosterone concentration measured after the study drug administration
Other Outcome Measures
- Nausea [30, 60, 90, 120, and 150 minutes after the study drug administration]
The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea.
- Systolic and diastolic blood pressure [30, 60, 90, 120, and 150 minutes after the study drug administration]
The change in systolic and diastolic blood pressure compared to baseline.
- Heart rate [30, 60, 90, 120, and 150 minutes after the study drug administration.]
The change in heart rate compared to baseline.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tartu University Hospital | Tartu | Estonia | 50406 |
Sponsors and Collaborators
- University of Tartu
- Tartu University Hospital
Investigators
- Principal Investigator: Vallo Volke, MD, PhD, University of Tartu, Tartu University Hosptial
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Lixi22