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 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.
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