Type 1 Diabetes MellitusPhase 1DIAB-01NCT02109315
Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.
A Phase 1 study testing Vitamine C and Liraglutide 6 mg in people with Type 1 Diabetes Mellitus, run by Anna Cruceta at 1 site in Spain.
Trial summary
To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes of endothelial function Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Vitamine C and Liraglutide 6 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to May 2015
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed and signed consent obtained before any trial-related activity . ( Trial-related activities are those procedures that were not performed during routine medical examination of the patient) .
- Diagnosis of type 1 diabetes.
- Patients who do not have autonomic dysfunction , defined by ( 1).
- Patients not showing episodes of hypoglycemia unawareness based on the methods of Gold et al (2) .
- Patients without microvascular complications of diabetes.
- Patients without macrovascular complications of diabetes.
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- Patients treated with multiple daily injections of insulin.
- No smoking .
- They should have a complete blood count, lipid profile, liver profile , renal profile and plasma electrolyte levels within normal values .
- No subject must have a history of hypertension or taking medication for high blood pressure .
- No subject should be taking medications known to affect the neuroendocrine responses to hypoglycemia or anti inflammatory
Who cannot join
- Known or suspected hypersensitivity to study some related products.
- Fertile women, lactating or pregnant, intend to become pregnant or who are not using adequate contraception, or men who have sexually active and are not sterilized surgically, those whose partners are not using a method adequate contraception.
- Clinical diagnosis of Type 2 Diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes of endothelial function
Read the detailed description
To investigate the effect of antioxidants (Vitamin C) on the vascular damage induced hypoglycemia in patients with type 1 diabetes. The vascular injury was evaluated in the same way as main objective. Checking the existence of a peripheral response to the action of GLP-1 due to oxidative stress.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Vitamine C, Liraglutide 6 mg
- 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.
Vitamine CDrug
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
Liraglutide 6 mgDrug
Liraglutide endovenous de 0.6 mg. one time a day
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide endovenous 6 mg | Experimental | Liraglutide endovenous de 0.6 mg. one time a day Receives: Drug: Liraglutide 6 mg |
| Vitamine C | Experimental | C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min Receives: Drug: Vitamine C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.
Measured: 8 weeks
Secondary outcomes (1)
Oxidative stress markers
Oxidative stress markers (nitrotyrosine and 8-iso prostaglandin F2 alpha plasma) in serum1 inflammation markers (serum sICAM-1, interleukin 6) 1
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Cruceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Antonio Ceriello A Ceriello, MD, Principal investigator, Hospital clínic i provincial de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109315
- Sponsor's protocol ID
- DIAB-01
- Acronym
- DIAB-01
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT02109315
- Acronym / sponsor ID
- DIAB-01 / DIAB-01
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anna CrucetaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 9 Apr 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.
To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes of endothelial function
Detailed description
To investigate the effect of antioxidants (Vitamin C) on the vascular damage induced hypoglycemia in patients with type 1 diabetes. The vascular injury was evaluated in the same way as main objective. Checking the existence of a peripheral response to the action of GLP-1 due to oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide endovenous 6 mg | Experimental | Drug: Liraglutide 6 mgLiraglutide endovenous de 0.6 mg. one time a day |
| Vitamine C | Experimental | Drug: Vitamine CC Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed and signed consent obtained before any trial-related activity . ( Trial-related activities are those procedures that were not performed during routine medical examination of the patient) .
- Diagnosis of type 1 diabetes.
- Patients who do not have autonomic dysfunction , defined by ( 1).
- Patients not showing episodes of hypoglycemia unawareness based on the methods of Gold et al (2) .
- Patients without microvascular complications of diabetes.
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to study some related products.
- Fertile women, lactating or pregnant, intend to become pregnant or who are not using adequate contraception, or men who have sexually active and are not sterilized surgically, those whose partners are not using a method adequate contraception.
- Clinical diagnosis of Type 2 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 |
|---|---|---|
| Vitamine CC Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min | Drug | Vitamine C |
| Liraglutide 6 mgLiraglutide endovenous de 0.6 mg. one time a day | Drug | Liraglutide endovenous 6 mg |
Primary outcome
Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.
Time frame: 8 weeks
1 secondary outcome
Oxidative stress markers
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Antonio Ceriello A Ceriello, MD principal investigator
Hospital clínic i provincial de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamine C and Liraglutide 6 mg in people with Type 1 Diabetes Mellitus, run by Anna Cruceta at 1 site in Spain.
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 3 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: withdrawn, as of the sponsor's last update on 15 Feb 2019. 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 Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery. (time frame: 8 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 15 Feb 2019.