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

Phase 3

• Conditions: Type 1 Diabetes; Insulin Dependent Diabetes; Autoimmune Diabetes; Juvenile Onset Diabetes Mellitus
• Interventions: Drug: Vildagliptin

• Registration Number: NCT01559025
• Lead Sponsor: Federal University of São Paulo

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2012-03-18
• Study First Posted: 2012-03-20
• Study Start: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14
• Primary Completion: 2015-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin	Patients will receive vildagliptin besides the conventional treatment with insulin

Primary Outcome Measures

Name	Time	Method
Beta cell function	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

Secondary Outcome Measures

Name	Time	Method
Immune and inflammatory profile	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	0,3,6, 9 and 12months	It will be obtained by the measure of glucagon and GLP-1 levels
Glycemic variability	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.

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil