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

NCT01559025 | Unknown Phase 3 DMC

• 1 other identifier: CLAF237ABR01T
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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. 1.To define the immune and inflammatory profile
2. 2.To define the secretion of glucagon and GLP-1
3. 3.To assess the glycemic variability

Conditions

Type 1 Diabetes; Insulin Dependent Diabetes; Juvenile Onset Diabetes Mellitus; Autoimmune Diabetes

Keywords

Type 1 diabetes; Vildagliptin; Galvus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Immune and inflammatory profile

  0,3,6,9,12th months

• Secretion of Glucagon and GLP-1

  0,3,6, 9 and 12months

• Glycemic variability

  0, 6 and 12months

Study Arms (2)

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

Drug: Vildagliptin

Interventions

Vildagliptin DRUG

Vildagliptin ( Galvus 50mg twice day) during one year

Also known as: Galvus, DPP-4 inhibitor

Vildagliptin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Hepatic, cardiac, pulmonary and hematologic disease

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Novartis: collaborator

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04022-001, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Vildagliptin; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Sérgio Dib

  FUSãoPaulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Valente

CONTACT

55(11)996146126; valentetati@yahoo.com.br

Sergio Dib

CONTACT

55(11)997397776; sergio.dib@unifesp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: March 20, 2012
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2017
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

BR (1)