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临床试验/NCT00513201
NCT00513201已完成4 期

Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

University of Campania "Luigi Vanvitelli"2 个研究点 分布在 1 个国家开始时间: 2007年8月8日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
试验地点
2
主要终点
Glycemic control in lyspro vs regular insulin treated patients

研究概览

简要总结

OBJECTIVE: To compare lispro insulin and regular insulin in the glycemic control of patients with liver cirrhosis and type 2 diabetes subjects. METHODS: 108 patients with liver cirrhosis and type 2 diabetes were randomly treated with regular insulin or lispro. After 122 weeks a cross-over was carried out and patients followed-up for 122 weeks. Then, all patients received a standard breakfast of 145 kcal following 12 U.I. of regular insulin or lispro, and C-peptide and insulin serum levels were determined over 300 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double

入排标准

年龄范围
48 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Insulin-treated diabetes mellitus and liver cirrhosis

排除标准

  • Oral hypoglycemic agents treated diabetes mellitus
  • Liver cancer

结局指标

主要结局

Glycemic control in lyspro vs regular insulin treated patients

Glycemic control in lyspro vs regular insulin in cirrhotic patients

次要结局

  • Tolerance to treatment and reduced postprandial hypoglycemia episodes

研究者

申办方类型
Other

研究点 (2)

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