NCT00546702已完成3 期
Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy
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
- 142
- 试验地点
- 2
- 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 To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.
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
- •Adult men and women (>18 years) with 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 transplantats, 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 in HbA1c.(from baseline (week 1) to weeks 12 and 26)
- Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.(from baseline to endpoint.)
研究者
研究点 (2)
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