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

Type 1 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01559025
• Other study ID #: CLAF237ABR01T
• Status: Recruiting
• Phase: Phase 3
• First received: November 30, 2011
• Last updated: May 13, 2014
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2014
• Source: Federal University of São Paulo
• Contact: Tatiana Valente
• Phone: 55(11)996146126
• Email: valentetati[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Vildagliptin
Vildagliptin ( Galvus 50mg twice day) during one year

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
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	No
Secondary	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	No
Secondary	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	No