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

Study Overview
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Brief Summary
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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: To define the immune and inflammatory profile To define the secretion of glucagon and GLP-1 To assess the glycemic variability

Detailed Description
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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.

Official Title
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Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in Residual β-cell Function and Inflammatory Markers in New-onset Type 1 Diabetes Mellitus.

Conditions
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Type 1 Diabetes, Insulin Dependent Diabetes, Juvenile Onset Diabetes Mellitus, Autoimmune Diabetes

Intervention / Treatment
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* Drug: Vildagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Insulin therapy<br>Patients will receive the conventional treatment with insulin | |
| Active Comparator: Vildagliptin<br>Patients will receive vildagliptin besides the conventional treatment with insulin | Drug: Vildagliptin<br>* Vildagliptin ( Galvus 50mg twice day) during one year<br>* Other names: DPP-4 inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta cell function | 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 | 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 | It will be obtained by the measure of glucagon and GLP-1 levels | 0,3,6, 9 and 12months | 
| Glycemic variability | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Vildagliptin, Galvus