Brief Summary

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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."

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 Type: Interventional
• Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: November 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Drug: Vildagliptin
  • Vildagliptin ( Galvus 50mg twice day) during one year

Arms, Groups and Cohorts in this Clinical Trial

• 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

Outcome Measures for this Clinical Trial

Primary 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
    Safety Issue?: No

Secondary Measures

• Immune and inflammatory profile
  • Time Frame: 0,3,6,9,12th months
    Safety Issue?: No
• Secretion of Glucagon and GLP-1
  • Time Frame: 0,3,6, 9 and 12months
    Safety Issue?: No
• Glycemic variability
  • Time Frame: 0, 6 and 12months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Federal University of São Paulo
• Collaborator
  • Novartis
• Provider of Information About this Clinical Study
  • Principal Investigator: Tatiana Valente, Principal Investigator - Federal University of São Paulo
• Overall Official(s)
  • Sérgio Dib, Principal Investigator, FUSãoPaulo
• Overall Contact(s)
  • Tatiana Valente, 55(11)96146126, valentetati@yahoo.com.br