NCT00545337已完成3 期
26-week, International Multicenter, Open, Non-randomized Phase III Clinical Trial for Evaluation of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Subjects With Type 1 Diabetes Mellitus Also Using Insulin Glargine
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of HbA1c
研究概览
简要总结
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type I diabetes mellitus (onset of diabetes under the age of 40),
- •an HbA1c range of >6.5 - <11%,
- •and on multiple injection regimen (more than 1 year of continuous insulin treatment),
- •body mass index <35.
排除标准
- •Active proliferative diabetic retinopathy,
- •Diabetes other than type I diabetes mellitus,
- •Pancreatectomised subjects,
- •Subjects who have undergone pancreas and or islet cell transplants,
- •Requiring treatment with not permited drugs during the study,
- •Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine,
- •Hypersensitivity to insulin,
- •Major systemic diseases,
- •Impaired hepatic or renal function
- •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
Change of HbA1c
时间窗: from baseline to endpoint
次要结局
- Change of HbA1c(from baseline to week 26)
- Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins(from baseline to endpoint)
研究者
研究点 (1)
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