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

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Novartis
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Insulin; Insulin, Globin Zinc; Vildagliptin

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