Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus
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Purpose
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:
- To define the immune and inflammatory profile
- To define the secretion of glucagon and GLP-1
- To assess the glycemic variability
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Insulin Dependent Diabetes Juvenile Onset Diabetes Mellitus Autoimmune Diabetes |
Drug: Vildagliptin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- Beta cell function [ Time Frame: 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 ] [ Designated as safety issue: No ]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
- Immune and inflammatory profile [ Time Frame: 0,3,6,9,12th months ] [ Designated as safety issue: No ]
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 [ Time Frame: 0,3,6, 9 and 12months ] [ Designated as safety issue: No ]It will be obtained by the measure of glucagon and GLP-1 levels
- Glycemic variability [ Time Frame: 0, 6 and 12months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 44 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Insulin therapy
Patients will receive the conventional treatment with insulin
|
|
|
Active Comparator: Vildagliptin
Patients will receive vildagliptin besides the conventional treatment with insulin
|
Drug: Vildagliptin
Vildagliptin ( Galvus 50mg twice day) during one year
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Tatiana Valente | 55(11)96146126 | valentetati@yahoo.com.br |
| Contact: Sergio Dib | 55(11)97397776 | sergio.dib@unifesp.br |
| Brazil | |
| Federal University of São Paulo | Not yet recruiting |
| São Paulo, Brazil, 04022-001 | |
| Contact: Tatiana Valente 55119614616 valentetati@yahoo.com.br | |
| Contact: Sergio Dib 551197397776 sergio.dib@unifesp.br | |
| Sub-Investigator: Monica Gabbay | |
| Sub-Investigator: Patricia Dualib | |
| Principal Investigator: | Sérgio Dib | FUSãoPaulo |
More Information
No publications provided
| Responsible Party: | Tatiana Valente, Principal Investigator, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01559025 History of Changes |
| Other Study ID Numbers: | CLAF237ABR01T |
| Study First Received: | November 30, 2011 |
| Last Updated: | March 18, 2012 |
| Health Authority: | United States: Food and Drug Administration Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Keywords provided by Federal University of São Paulo:
|
Type 1 diabetes Vildagliptin Galvus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Vildagliptin |
Insulin Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013