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Search / Trial NCT01559025

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

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · Mar 18, 2012

Trial Information

Current as of May 21, 2025

Unknown status

Keywords

Type 1 Diabetes Vildagliptin Galvus

ClinConnect Summary

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 n...

Gender

ALL

Eligibility criteria

  • 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

About Federal University Of São Paulo

The Federal University of São Paulo (Universidade Federal de São Paulo - UNIFESP) is a prestigious institution dedicated to advancing education, research, and healthcare in Brazil. Renowned for its commitment to innovation and excellence, UNIFESP plays a pivotal role in clinical research, focusing on a multidisciplinary approach to improve health outcomes. The university fosters collaboration among researchers, healthcare professionals, and community stakeholders, ensuring that clinical trials conducted under its auspices adhere to rigorous ethical standards and contribute valuable insights to the medical field. With a rich history of academic achievement and a strong emphasis on translational research, UNIFESP is a key player in the development of new therapies and medical interventions.

Locations

São Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Sérgio Dib

Principal Investigator

FUSãoPaulo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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