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Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01559025
Recruitment Status : Unknown
Verified May 2014 by Tatiana Valente, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : March 20, 2012
Last Update Posted : May 14, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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. To define the secretion of glucagon and GLP-1
  3. To assess the glycemic variability

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Insulin Dependent Diabetes Juvenile Onset Diabetes Mellitus Autoimmune Diabetes Drug: Vildagliptin Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : March 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Insulin therapy
Patients will receive the conventional treatment with insulin
Active Comparator: Vildagliptin
Patients will receive vildagliptin besides the conventional treatment with insulin
Drug: Vildagliptin
Vildagliptin ( Galvus 50mg twice day) during one year
Other Names:
  • Galvus
  • DPP-4 inhibitor


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Immune and inflammatory profile [ Time Frame: 0,3,6,9,12th months ]

    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.


  2. Secretion of Glucagon and GLP-1 [ Time Frame: 0,3,6, 9 and 12months ]
    It will be obtained by the measure of glucagon and GLP-1 levels

  3. Glycemic variability [ Time Frame: 0, 6 and 12months ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Hepatic, cardiac, pulmonary and hematologic disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559025


Contacts
Contact: Tatiana Valente 55(11)996146126 valentetati@yahoo.com.br
Contact: Sergio Dib 55(11)997397776 sergio.dib@unifesp.br

Locations
Brazil
Federal University of São Paulo Recruiting
São Paulo, Brazil, 04022-001
Contact: Tatiana Valente    55119614616    valentetati@yahoo.com.br   
Contact: Sergio Dib    551197397776    sergio.dib@unifesp.br   
Sub-Investigator: Monica Gabbay         
Sponsors and Collaborators
Federal University of São Paulo
Novartis
Investigators
Principal Investigator: Sérgio Dib FUSãoPaulo
More Information

Responsible Party: Tatiana Valente, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01559025     History of Changes
Other Study ID Numbers: CLAF237ABR01T
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Tatiana Valente, Federal University of São Paulo:
Type 1 diabetes
Vildagliptin
Galvus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Vildagliptin
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action