HealthyPhase 4NCT02089256
Effect of Repeated Administration of Liraglutide on Insulinogenic Indices
A Phase 4 study testing Liraglutide in people with Healthy, run by University of Tartu at 1 site in Estonia.
Trial summary
The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEstonia
- Study dates
- Jun 2014to Mar 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight 50-100 kg
Who cannot join
- Chronic disease
- Concomitant drug use
- Pregnancy or lactation
- Fasting glucose >6 mmol/L.
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be performed without medication and repeated 12 hours after first dose of liraglutide and after 3 weeks of treatment with liraglutide.
- Conditions
- Healthy
- Being tested
- Liraglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
Graded glucose infusion test (GGIT)will be performed on baseline. 1 week later treatment with liraglutide 0.6mg/day (injected between 21.00-23.00) will be initiated.
GGIT will be repeated 12 hours after first injection and after 21 days on-treatment (12 hours after last injection).
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Liraglutide 0.6 mg/day subcutaneously. Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the glucose-sensitivity of the beta cells
Graded glucose infusion test will be used to create insulin secretion rate- plasma glucose curve. The primary outcome is the change of the slope of the curve from baseline after acute administration of liraglutide compared to the repeated administration (after 3-weeks of treatment).
Measured: baseline, first dose, after 3-weeks on treatment
Secondary outcomes (1)
Effects on adrenal hormones
change in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide.
Measured: baseline, acute administration, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vallo Volke, University of Tartu
- Investigators
- Vallo Volke, MD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089256
- Sponsor's protocol ID
- LI20/1101
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.
PubMed 36800161Sedman T, Vasar E, Volke V. Tolerance Does Not Develop Toward Liraglutide's Glucose-Lowering Effect. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2335-2339. doi: 10.1210/jc.2017-00199.
PubMed 28379427Sedman T, Heinla K, Vasar E, Volke V. Liraglutide Treatment May Affect Renin and Aldosterone Release. Horm Metab Res. 2017 Jan;49(1):5-9. doi: 10.1055/s-0042-109065. Epub 2016 Jun 14.
PubMed 27300475
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Administration of Liraglutide on Insulinogenic Indices
- ClinicalTrials.gov ID
- NCT02089256
- Acronym / sponsor ID
- LI20/1101
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Mar 2014 (estimated)
- 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 study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be performed without medication and repeated 12 hours after first dose of liraglutide and after 3 weeks of treatment with liraglutide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideLiraglutide 0.6 mg/day subcutaneously. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Weight 50-100 kg
Key exclusion criteria (4 listed)
- Chronic disease
- Concomitant drug use
- Pregnancy or lactation
- Fasting glucose >6 mmol/L.
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 |
|---|---|---|
| LiraglutideAlso: VictozaGraded glucose infusion test (GGIT)will be performed on baseline. 1 week later treatment with liraglutide 0.6mg/day (injected between 21.00-23.00) will be initiated. GGIT will be repeated 12 hours after first injection and after 21 days on-treatment (12 hours after last injection). | Drug | Liraglutide |
Primary outcome
Change in the glucose-sensitivity of the beta cells
Time frame: baseline, first dose, after 3-weeks on treatment
Graded glucose infusion test will be used to create insulin secretion rate- plasma glucose curve. The primary outcome is the change of the slope of the curve from baseline after acute administration of liraglutide compared to the repeated administration (after 3-weeks of treatment).
1 secondary outcome
Effects on adrenal hormones
Time frame: baseline, acute administration, 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 36800161Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.
- Derived from this study: PubMed 28379427Sedman T, Vasar E, Volke V. Tolerance Does Not Develop Toward Liraglutide's Glucose-Lowering Effect. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2335-2339. doi: 10.1210/jc.2017-00199.
- Derived from this study: PubMed 27300475Sedman T, Heinla K, Vasar E, Volke V. Liraglutide Treatment May Affect Renin and Aldosterone Release. Horm Metab Res. 2017 Jan;49(1):5-9. doi: 10.1055/s-0042-109065. Epub 2016 Jun 14.
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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 principal investigator
University of Tartu
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 Liraglutide in people with Healthy, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the glucose-sensitivity of the beta cells (time frame: baseline, first dose, after 3-weeks on treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089256, which also lists 3 linked publications.
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 1 Apr 2015; AzTrials last refreshed its copy on 8 Nov 2026.