NCT01235819已完成4 期
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Command Hospital, India1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in insulin requirement
研究概览
简要总结
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.
详细描述
Inclusion criteria T1DM <3 months GAD Antibody+ Stimulated C peptide<0.5ng/ml Ketosis at onset Age < 30 yr Exclusion criteria Age > 30 yr Pancreatic disease significant systemic complication
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
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1DM <3 months
- •GAD Antibody+ or Stimulated C peptide<0.5 ng/ml
- •Ketosis at onset
- •Age < 30 yr
排除标准
- •Age > 30 yr
- •Pancreas disease
- •Significant systemic disease
研究组 & 干预措施
Insulin alone
Active Comparator
Type 1 DM only on Insulin
干预措施: Insulin (Drug)
Insulin and Exenatide
Active Comparator
Newly detected Type 1 DM on Insulin and exenatide
干预措施: Exenatide (Drug)
Insulin and Sitagliptin
Active Comparator
Newly detected Type 1 DM using Insulin and Sitagliptin
干预措施: Sitagliptin (Drug)
结局指标
主要结局
change in insulin requirement
时间窗: one year
To assess the change in insulin requirement with use of GLP 1 analogues or DPP 4 inhibitors along with insulin in type 1 diabetes
次要结局
- C peptide response(at the end of one year)
研究者
KVS Hari Kumar
Endocrinologist
Command Hospital, India
研究点 (1)
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