NCT00322075已完成4 期
Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- patients´satisfaction
研究概览
简要总结
Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year
排除标准
- •Diabetic ketoacidosis
- •Any other severe disease
- •Pregnancy or fertile female without contraception
- •Alcohol/drug abuse, selected prohibited concomitant medication
- •Nightshift work
结局指标
主要结局
patients´satisfaction
3 days continual glycaemic profile fluctuation
occurrence of adverse events
HbA1c
FBG
BMI
total daily dose of insulin and ratio of doses of basal/prandial insulines
次要结局
未报告次要终点
研究者
研究点 (2)
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