Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT01559025|
Recruitment Status : Unknown
Verified May 2014 by Tatiana Valente, Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : March 20, 2012
Last Update Posted : May 14, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Insulin Dependent Diabetes Juvenile Onset Diabetes Mellitus Autoimmune Diabetes||Drug: Vildagliptin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2017|
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
Vildagliptin ( Galvus 50mg twice day) during one year
- 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 ]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
- Immune and inflammatory profile [ Time Frame: 0,3,6,9,12th months ]
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.
- Secretion of Glucagon and GLP-1 [ Time Frame: 0,3,6, 9 and 12months ]It will be obtained by the measure of glucagon and GLP-1 levels
- Glycemic variability [ Time Frame: 0, 6 and 12months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559025
|Contact: Tatiana Valente||55(11)firstname.lastname@example.org|
|Contact: Sergio Dib||55(11)email@example.com|
|Federal University of São Paulo||Recruiting|
|São Paulo, Brazil, 04022-001|
|Contact: Tatiana Valente 55119614616 firstname.lastname@example.org|
|Contact: Sergio Dib 551197397776 email@example.com|
|Sub-Investigator: Monica Gabbay|
|Principal Investigator:||Sérgio Dib||FUSãoPaulo|