Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in Residual β-cell Function and Inflammatory Markers in New-onset Type 1 Diabetes Mellitus.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Beta cell function
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Hepatic, cardiac, pulmonary and hematologic disease
研究组 & 干预措施
Vildagliptin
Patients will receive vildagliptin besides the conventional treatment with insulin
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Beta cell function
时间窗: 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
次要结局
- 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)
研究者
Tatiana Valente
Principal Investigator
Federal University of São Paulo