NCT00489190已完成4 期
Local, Open, Non-Randomized, Phase IV Clinical Study for the Collection of Data Regarding the Drug Portability Received During the Treatment With Subcutaneous Injection of Apidra Glulisine (HMR1964) to Patients With Diabetes Mellitus 1st Type
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
- 45
- 试验地点
- 1
- 主要终点
- Dynamics compared with the initial level of glycemia and insulin dosages.
研究概览
简要总结
To collect effectiveness and safety data during the treatment with Apidra glulisine (HMR1964) by means of subcutaneous injections to patients with Diabetes Mellitus 1st type during 12 weeks-active phase.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus 1st type, with НbA1c level in the range of ≥ 6,5 - <=11%, receiving the regimen of multiple injections of insulin during one year.
排除标准
- •Active proliferative diabetic retinopathy connected with focal or panretinal photocoagulation or vitrectomy carried out within 6 months before visit 1, or any unstable (quickly progressive) form of retinopathy, which may need in surgical intervention (including laser photocoagulation) during study
- •Diabetes Mellitus of the 2nd type
- •Patients transmitted pancreatectomy
- •Patients transmitted transplantation of pancreas or islet cells
- •Probable therapy by means of products not approved by study minutes during the study
- •Anamnestic indications of convulsive disorders
- •Allergic reaction on insulin or any filler of preparation Apidra (glulisine)
- •Clinical serious diseases of cardiovascular system, liver, nervous system, endocrine system, oncologic diseases or other serious system diseases, which complicate keeping of minutes or interpretation of study results, and, at the investigator's opinion, impede the safe participation of patients in study
- •Drug addiction or alcoholism
- •Disturbance of liver functions confirmed with the increase of ALT or AST activity up to the level twice as high as the upper standard limit (these indications may not be single)
- •Disturbance of functions of kidneys confirmed with the level of creatinine in serum that is more than 177 mµmol/l at visit 1 (this indication may not be single)
- •Pregnancy or breast-feeding
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Dynamics compared with the initial level of glycemia and insulin dosages.
时间窗: 12 weeks
Dynamics НbA1c in the final point compared with the initial level.
时间窗: end of the study
次要结局
- Evaluation of frequency of glycemia episodes. Also undesirable events, Influence on indexes of general clinical analysis of blood and biochemical analysis of blood.(from the beginning to the end of the study)
研究者
研究点 (1)
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