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

May 13, 2014 updated by: Tatiana Valente, Federal University of São Paulo

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04022-001
        • Recruiting
        • Federal University of São Paulo
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Monica Gabbay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0,3,6,9,12th months
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
0,3,6, 9 and 12months
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.
0, 6 and 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Novartis

Investigators

  • Principal Investigator: Sérgio Dib, FUSãoPaulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

March 18, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237ABR01T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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