Type 1 DiabetesPhase 3NCT01559025
Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus
A Phase 3 study testing Vildagliptin in people with Type 1 Diabetes and Insulin Dependent Diabetes, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months). The secondary objectives are: 1. To define the immune and inflammatory profile 2. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Type 1 Diabetes, Insulin Dependent Diabetes, Juvenile Onset Diabetes Mellitus
- What is being tested?
- Vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Mar 2017
- Phase
- Phase 3
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 35 years
- Up to 6 months of clinical diagnosis
- Fasting C-peptide ≥ 0.25 ng / ml
- HbA1C <9.0%
- Positive autoantibodies (anti-GAD, Anti-Insulin and Anti-IA2)
- Without chronic complications
Who cannot join
- Hepatic, cardiac, pulmonary and hematologic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of São Paulo
São Paulo, São Paulo, 04022-001
Tatiana Valente, 55119614616, valentetati@yahoo.com.br
Sergio Dib, 551197397776, sergio.dib@unifesp.br
About this study
Official title: Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in Residual β-cell Function and Inflammatory Markers in New-onset Type 1 Diabetes Mellitus.
The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months).
The secondary objectives are:
- To define the immune and inflammatory profile
- To define the secretion of glucagon and GLP-1
- To assess the glycemic variability
Read the detailed description
Clinical and autopsy studies show that up to 30% of patients with type 1 diabetes mellitus show a detectable β-cell function at clinical diabetes. The preservation of this endogenous insulin production, even if it is small, can have a great impact on the evolution of long-term disease through improving glycemic control, reducing chronic diabetes complications and hypoglycemia. Strategies for preventing the loss of beta cell are based on stopping the autoimmune process and also in the preservation and regeneration of beta cells. Currently have been questioned the potential use of GLP-1 for new-onset type 1 diabetes. The justification for this issue is based on the fact that this class of drugs, besides acting on insulin secretion and glucose regulation, may be effective to preserve and expand beta cell mass, which has been shown in animals. Ideal candidates for this treatment are newly diagnosed patients who still have significant viable beta cell mass.
- Conditions
- Type 1 Diabetes, Insulin Dependent Diabetes, Juvenile Onset Diabetes Mellitus, Autoimmune Diabetes
- Being tested
- Vildagliptin
- Keywords
- Type 1 diabetes, Vildagliptin, Galvus
- 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.
VildagliptinDrug
Also called Galvus, DPP-4 inhibitor
Vildagliptin ( Galvus 50mg twice day) during one year
| Study group | Role | What they receive |
|---|---|---|
| Insulin therapy | No intervention | Patients will receive the conventional treatment with insulin |
| Vildagliptin | Active comparator | Patients will receive vildagliptin besides the conventional treatment with insulin Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta cell function
The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months). It will be measured by the area under the curve of stimulated C peptide within the first 2 hours
Measured: C peptide will be measured by the area under the curve of stimulated C peptide within the first 2 hours every 3 months up to one year
Secondary outcomes (3)
Immune and inflammatory profile
Inflammatory profile will be measured by some markers such as TNF-alpha, IL-10 and PCR.
Immune profile will be obtained by the expression of FOXP3 in both groups.
Measured: 0,3,6,9,12th months
Secretion of Glucagon and GLP-1
It will be obtained by the measure of glucagon and GLP-1 levels
Measured: 0,3,6, 9 and 12months
Glycemic variability
To evaluate the glycemic variability, it will be installed the continuos glucose monitoring system (CGMS) for seven days during the 0, 6 and 12 months.
Measured: 0, 6 and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2017 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Tatiana Valente, Federal University of São Paulo
- Investigators
- Sérgio Dib, Principal investigator, FUSãoPaulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559025
- Sponsor's protocol ID
- CLAF237ABR01T
- Status last verified
- May 2014
- First submitted
- 30 Nov 2011
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in Residual β-cell Function and Inflammatory Markers in New-onset Type 1 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT01559025
- Acronym / sponsor ID
- CLAF237ABR01T
- Conditions
- Type 1 Diabetes, Insulin Dependent Diabetes, Juvenile Onset Diabetes Mellitus, Autoimmune Diabetes
- Keywords
- Type 1 diabetes, Vildagliptin, Galvus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 20 Mar 2012 (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 primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months).
The secondary objectives are:
- To define the immune and inflammatory profile
- To define the secretion of glucagon and GLP-1
- To assess the glycemic variability
Detailed description
Clinical and autopsy studies show that up to 30% of patients with type 1 diabetes mellitus show a detectable β-cell function at clinical diabetes. The preservation of this endogenous insulin production, even if it is small, can have a great impact on the evolution of long-term disease through improving glycemic control, reducing chronic diabetes complications and hypoglycemia. Strategies for preventing the loss of beta cell are based on stopping the autoimmune process and also in the preservation and regeneration of beta cells. Currently have been questioned the potential use of GLP-1 for new-onset type 1 diabetes. The justification for this issue is based on the fact that this class of drugs, besides acting on insulin secretion and glucose regulation, may be effective to preserve and expand beta cell mass, which has been shown in animals. Ideal candidates for this treatment are newly diagnosed patients who still have significant viable beta cell mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin therapy | No intervention | –Patients will receive the conventional treatment with insulin |
| Vildagliptin | Active comparator | Drug: VildagliptinPatients will receive vildagliptin besides the conventional treatment with insulin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18 to 35 years
- Up to 6 months of clinical diagnosis
- Fasting C-peptide ≥ 0.25 ng / ml
- HbA1C <9.0%
- Positive autoantibodies (anti-GAD, Anti-Insulin and Anti-IA2)
Key exclusion criteria (1 listed)
- Hepatic, cardiac, pulmonary and hematologic disease
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 |
|---|---|---|
| VildagliptinAlso: Galvus, DPP-4 inhibitorVildagliptin ( Galvus 50mg twice day) during one year | Drug | Vildagliptin |
Primary outcome
Beta cell function
Time frame: C peptide will be measured by the area under the curve of stimulated C peptide within the first 2 hours every 3 months up to one year
The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months). It will be measured by the area under the curve of stimulated C peptide within the first 2 hours
3 secondary outcomes
Immune and inflammatory profile
Time frame: 0,3,6,9,12th months
Secretion of Glucagon and GLP-1
Time frame: 0,3,6, 9 and 12months
Glycemic variability
Time frame: 0, 6 and 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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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.
Sérgio Dib principal investigator
FUSãoPaulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vildagliptin in people with Type 1 Diabetes and Insulin Dependent Diabetes, run by Federal University of São Paulo at 1 site in Brazil.
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 6 inclusion and 1 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 14 May 2014. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Tatiana Valente (55(11)996146126, valentetati@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta cell function (time frame: C peptide will be measured by the area under the curve of stimulated C peptide within the first 2 hours every 3 months up to one year). 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 14 May 2014.