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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Federal University of São Paulo
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Tatiana Valente, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01559025
First received: November 30, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Type 1 Diabetes
Insulin Dependent Diabetes
Juvenile Onset Diabetes Mellitus
Autoimmune Diabetes
Drug: Vildagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Immune and inflammatory profile [ Time Frame: 0,3,6,9,12th months ] [ Designated as safety issue: No ]

    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.


  • Secretion of Glucagon and GLP-1 [ Time Frame: 0,3,6, 9 and 12months ] [ Designated as safety issue: No ]
    It will be obtained by the measure of glucagon and GLP-1 levels

  • Glycemic variability [ Time Frame: 0, 6 and 12months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 44
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Vildagliptin
  • Galvus
  • DPP-4 inhibitor

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tatiana Valente, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01559025     History of Changes
Other Study ID Numbers: CLAF237ABR01T
Study First Received: November 30, 2011
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

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

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

ClinicalTrials.gov processed this record on October 23, 2014