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| Name | Class |
|---|---|
| Tartu University Hospital | OTHER |
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The current study has two aims:
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, healthy volunteers | Placebo Comparator | Sodium chloride 0.9% solution. Subcutaneous injection administered once. |
|
| Lixisenatide 10 micrograms, healthy volunteers | Active Comparator | Lixisenatide 10 micrograms. Subcutaneous injection administered once. |
|
| Placebo, type 1 diabetic patients | Placebo Comparator | Sodium chloride 0.9% solution. Subcutaneous injection administered once. |
|
| Lixisenatide 10 micrograms, type 1 diabetic patients | Active Comparator | Lixisenatide 10 micrograms. Subcutaneous injection administered once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | s/c injection |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Healthy volunteers:
Patients with type 1 diabetes:
Exclusion Criteria:
Healthy volunteers:
Patients with type 1 diabetes:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vallo Volke, MD, PhD | Contact | 7374330 | +372 | vallo.volke@ut.ee |
| Ingrid Reppo, MD | Contact | 53318642 | +372 | ingrid.reppo@kliinikum.ee |
| Name | Affiliation | Role |
|---|---|---|
| Vallo Volke, MD, PhD | University of Tartu, Tartu University Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Recruiting | Tartu | 50406 | Estonia |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D012996 | Solutions |
| C479460 | lixisenatide |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Blinded randomised two group crossover
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| Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector | Drug | s/c injection |
|
|
| 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 |
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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |
| D004364 | Pharmaceutical Preparations |