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Clinical Trial Details

Trial ID: L2245
Source ID: NCT01559025
Associated Drug: Vildagliptin
Title: Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Insulin Dependent Diabetes|Juvenile Onset Diabetes Mellitus|Autoimmune Diabetes
Interventions: DRUG: Vildagliptin
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: Federal University of São Paulo | Collaborators: Novartis
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-03
Completion Date: 2017-03
Results First Posted:
Last Update Posted: 2014-05-14
Locations: Federal University of São Paulo, São Paulo, 04022-001, Brazil
URL: https://clinicaltrials.gov/show/NCT01559025