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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin therapy | No Intervention | Patients will receive the conventional treatment with insulin | |
| Vildagliptin | Active Comparator | Patients will receive vildagliptin besides the conventional treatment with insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Vildagliptin ( Galvus 50mg twice day) during one year |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Valente | Contact | 55(11)996146126 | valentetati@yahoo.com.br | |
| Sergio Dib | Contact | 55(11)997397776 | sergio.dib@unifesp.br |
| Name | Affiliation | Role |
|---|---|---|
| Sérgio Dib | FUSãoPaulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo | Recruiting | São Paulo | São Paulo | 04022-001 | Brazil |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |