HealthyPhase 4NCT05804513
The Effect of Lixisenatide on the Effect of Pituitary Hormones
A Phase 4 study testing Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector in people with Healthy and Type 1 Diabetes, run by University of Tartu at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 1 Diabetes
- What is being tested?
- Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEstonia
- Study dates
- 17 Apr 2023to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers:
- male sex
- age 18-60 years
- body weight > 65 kg
- Patients with type 1 diabetes:
- type 1 diabetes
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- male sex
- age 18-60 years
- body weight > 65 kg
- c-peptide in fasting blood sample <0,1 nmol/l
- HbA1c < 8,5%
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, 50406
Ingrid Reppo, 53318642 ext. +372, ingrid.reppo@kliinikum.ee
Vallo Volke, vallo.volke@ut.ee
About this study
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).
Read the 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.
- Conditions
- Healthy, Type 1 Diabetes
- Being tested
- Placebo, Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sodium chloride 0.9% solution
s/c injection
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen InjectorDrug
Also called Lyxumia
s/c injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo, healthy volunteers | Placebo comparator | Sodium chloride 0.9% solution. Subcutaneous injection administered once. Receives: Drug: Placebo |
| Lixisenatide 10 micrograms, healthy volunteers | Active comparator | Lixisenatide 10 micrograms. Subcutaneous injection administered once. Receives: Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector |
| Placebo, type 1 diabetic patients | Placebo comparator | Sodium chloride 0.9% solution. Subcutaneous injection administered once. Receives: Drug: Placebo |
| Lixisenatide 10 micrograms, type 1 diabetic patients | Active comparator | Lixisenatide 10 micrograms. Subcutaneous injection administered once. Receives: Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-150 minutes after study drug administration
Secondary outcomes (8)
Growth hormone peak
Maximum growth hormone concentration measured after study drug administration.
Measured: 30, 60, 90, 120, and 150 minutes after the study drug administration.
Glucose nadir
Lowest glucose concentration measured after the study drug administration
Measured: 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
Measured: 30, 60, 90, 120, and 150 minutes after the study drug administration
Cortisol peak
Maximum cortisol concentration measured after the study drug administration
Measured: 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
Measured: 30, 60, 90, 120, and 150 minutes after the study drug administration
Prolactin peak
Maximum prolactin concentration measured after the study drug administration
Measured: 30, 60, 90, 120, and 150 minutes after the study drug administration
Copeptin peak
Maximum copeptin concentration measured after the study drug administration
Measured: 30, 60, 90, 120, and 150 minutes after the study drug administration
Aldosterone peak
Maximum aldosterone concentration measured after the study drug administration
Measured: 30, 60, 90, 120, and 150 minutes after the study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start17 Apr 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Blinded randomised two group crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Tartu University Hospital
- Responsible party
- Principal investigator, Vallo Volke, University of Tartu
- Investigators
- Vallo Volke, MD, PhD, Principal investigator, University of Tartu, Tartu University Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804513
- Sponsor's protocol ID
- Lixi22
- Status last verified
- Jun 2023
- First submitted
- 27 Mar 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lixisenatide on the Effect of Pituitary Hormones
- ClinicalTrials.gov ID
- NCT05804513
- Acronym / sponsor ID
- Lixi22
- Conditions
- Healthy, Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Tartu University Hospital
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Blinded randomised two group crossover
| Arm | Type | Receives |
|---|---|---|
| Placebo, healthy volunteers | Placebo comparator | Drug: PlaceboSodium chloride 0.9% solution. Subcutaneous injection administered once. |
| Lixisenatide 10 micrograms, healthy volunteers | Active comparator | Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen InjectorLixisenatide 10 micrograms. Subcutaneous injection administered once. |
| Placebo, type 1 diabetic patients | Placebo comparator | Drug: PlaceboSodium chloride 0.9% solution. Subcutaneous injection administered once. |
| Lixisenatide 10 micrograms, type 1 diabetic patients | Active comparator | Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen InjectorLixisenatide 10 micrograms. Subcutaneous injection administered once. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy volunteers:
- Patients with type 1 diabetes:
Key exclusion criteria (9 listed)
- Healthy volunteers:
- Patients with type 1 diabetes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Sodium chloride 0.9% solutions/c injection | Drug | Placebo, healthy volunteers, Placebo, type 1 diabetic patients |
| Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen InjectorAlso: Lyxumias/c injection | Drug | Lixisenatide 10 micrograms, healthy volunteers, Lixisenatide 10 micrograms, type 1 diabetic patients |
Primary outcome
Growth hormone area under the curve.
Time frame: 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.
8 secondary outcomes
Growth hormone peak
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration.
Glucose nadir
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration
C-peptide peak
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration
Cortisol peak
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration
Adrenocorticotropic hormone (ACTH) peak
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration
Prolactin peak
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration
Copeptin peak
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration
Aldosterone peak
Time frame: 30, 60, 90, 120, and 150 minutes after the study drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vallo Volke, MD, PhD principal investigator
University of Tartu, Tartu University Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector in people with Healthy and Type 1 Diabetes, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vallo Volke, MD, PhD (7374330 ext. +372, vallo.volke@ut.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth hormone area under the curve. (time frame: 0-150 minutes after study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.