Trials / Unknown
UnknownNCT01559025
Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus
Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in Residual β-cell Function and Inflammatory Markers in New-onset Type 1 Diabetes Mellitus.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- Federal University of São Paulo · Academic / Other
- Sex
- All
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vildagliptin | Vildagliptin ( Galvus 50mg twice day) during one year |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-03-01
- Completion
- 2017-03-01
- First posted
- 2012-03-20
- Last updated
- 2014-05-14
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01559025. Inclusion in this directory is not an endorsement.