NCT03563794Unknown4 期
Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- blood glucose
研究概览
简要总结
The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30≤ age≤70 years old
- •BMI 18.0-28.0 Kg/m2
- •HbA1c ≥8.5%
- •Negtive GAD、ICA、IAA
- •Patients do not use antihyperglycemia drugs
- •Patients use antihyperglycemia drugs for ≥8 weeks(exclusion of DPP-4 inhibitors and GLP-1 receptor agonist)
排除标准
- •Congestive heart failure (New York Heart Association Functional Classification III-IV)
- •ALT or AST> 2 times above normal,GFR <50ml/min
- •Severe infection in the previous 3 months
- •Severely acute or chronic diabetic complications
- •Patients who were taking medications,known to affect glycaemic control, such as glucocorticoids(aside from antidiabetic medications)
- •History of pancreatitis
- •Trauma or patients operating at a scheduled time
- •Any mental health condition
研究组 & 干预措施
CSII(insulin Lispro)+Vildagliptin
Experimental
Vildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
干预措施: CSII+Vildagliptin (Drug)
CSII(insulin Lispro)
Active Comparator
T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
干预措施: CSII(insulin Lispro) (Drug)
结局指标
主要结局
blood glucose
时间窗: 7 days
changes from baseline in FPG and 2hPBG
次要结局
- hypoglycemia(7 days)
研究者
研究点 (1)
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