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

NCT01559025 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-05-14

No results posted yet for this study

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

Conditions

  • Type 1 Diabetes
  • Insulin Dependent Diabetes
  • Juvenile Onset Diabetes Mellitus
  • Autoimmune Diabetes

Interventions

DRUG

Vildagliptin

Vildagliptin ( Galvus 50mg twice day) during one year

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Sérgio Dib · FUSãoPaulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-03-31
Completion
2017-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01559025 on ClinicalTrials.gov