NCT00607737已完成4 期
Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus
Lise Tarnow1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年1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
- 40
- 试验地点
- 1
- 主要终点
- laser doppler blood flow
研究概览
简要总结
To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes
- The patient serves as his own control, n=100 patients with diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus
- •HbA1c<11 %
- •BMI: 20-35 kg/m2
- •Insulin detemir naive
- •Basal insulin dose>20E
排除标准
- •Known allergy to study drug
- •Current steroid or antiallergic treatment
- •Lipodystrophy
- •Change in insulin and antihypertensive treatment < 30 days
- •Smokers or alcoholics
研究组 & 干预措施
1
Experimental
insulin detemir
干预措施: insulin detemir (Drug)
2
Placebo Comparator
saline
干预措施: saline (Drug)
结局指标
主要结局
laser doppler blood flow
时间窗: 10 minutes - 7 days
次要结局
- insulin detemir specific antibodies(3 months)
- clinical signs(10 min - 7 days)
研究者
Lise Tarnow
professor
Steno Diabetes Center Copenhagen
研究点 (1)
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