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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

November 30, 2011
May 13, 2014
March 2014
March 2015   (final data collection date for 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 ] [ 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
Same as current
Complete list of historical versions of study NCT01559025 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus
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:

  1. To define the immune and inflammatory profile
  2. To define the secretion of glucagon and GLP-1
  3. To assess the glycemic variability

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Insulin Dependent Diabetes
  • Juvenile Onset Diabetes Mellitus
  • Autoimmune Diabetes
Drug: Vildagliptin
Vildagliptin ( Galvus 50mg twice day) during one year
Other Names:
  • Vildagliptin
  • Galvus
  • DPP-4 inhibitor
  • 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
    Intervention: Drug: Vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
March 2017
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
No
Contact: Tatiana Valente 55(11)996146126 valentetati@yahoo.com.br
Contact: Sergio Dib 55(11)997397776 sergio.dib@unifesp.br
Brazil
 
NCT01559025
CLAF237ABR01T
Yes
Tatiana Valente, Federal University of São Paulo
Federal University of São Paulo
Novartis
Principal Investigator: Sérgio Dib FUSãoPaulo
Federal University of São Paulo
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP