Type 1 DiabetesPhase 2NCT01782261
Incretin Effect on the Immunological Phenotype
A Phase 2 study testing Liraglutide and Saxagliptin in people with Type 1 Diabetes, run by Medical University of Graz at 1 site in Austria.
Trial summary
Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Liraglutide and Saxagliptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2012to Feb 2015
- Phase
- Phase 2
- 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
- -healthy subjects or patients with type 1 diabetes
Who cannot join
- pregnancy
- treatment with GLP-1-Analoga (Liraglutide, Exenatide)
- treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)
- chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects
Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes
Read the detailed description
Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.
- Conditions
- Type 1 Diabetes
- Being tested
- Liraglutide, Saxagliptin
- Keywords
- autoimmune disease, diabetes type 1, incretin effect
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
once daily subcutaneous injection
SaxagliptinDrug
Also called Onglyza
once daily tablet
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg. Receives: Drug: Liraglutide |
| Saxagliptin | Active comparator | Saxagliptin 5mg tablet by mouth every day for 4 weeks Receives: Drug: Saxagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of regulatory FOXP3+ T cells
the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Immunophenotyping
The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R Pieber, Professor, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782261
- Sponsor's protocol ID
- ADPP004
- Other IDs
- 2011-006300-12
- Status last verified
- Oct 2016
- First submitted
- 30 Jan 2013
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT01782261
- Acronym / sponsor ID
- ADPP004
- Conditions
- Type 1 Diabetes
- Keywords
- autoimmune disease, diabetes type 1, incretin effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Feb 2013 (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.
Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes
Detailed description
Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideLiraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg. |
| Saxagliptin | Active comparator | Drug: SaxagliptinSaxagliptin 5mg tablet by mouth every day for 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -healthy subjects or patients with type 1 diabetes
Key exclusion criteria (4 listed)
- pregnancy
- treatment with GLP-1-Analoga (Liraglutide, Exenatide)
- treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)
- chronic disease including a long-term medication over 4 weeks per year (except 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 |
|---|---|---|
| LiraglutideAlso: Victozaonce daily subcutaneous injection | Drug | Liraglutide |
| SaxagliptinAlso: Onglyzaonce daily tablet | Drug | Saxagliptin |
Primary outcome
Increase of regulatory FOXP3+ T cells
Time frame: 4 weeks
the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks
1 secondary outcome
Immunophenotyping
Time frame: 4 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 11 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Thomas R Pieber, Professor principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide and Saxagliptin in people with Type 1 Diabetes, run by Medical University of Graz at 1 site in Austria.
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 11 Oct 2016. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Increase of regulatory FOXP3+ T cells (time frame: 4 weeks). 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 11 Oct 2016.