NCT00539448已完成4 期
Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.
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
- Sanofi
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Evaluating the Glycemic control of the regimen : Change in A1C levels
研究概览
简要总结
Primary objective :
To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.
Secondary objective :
- Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I DM.
- Recording 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type I diabetic patients
- •Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
- •BMI, 26-40 kg/m2
- •HbA1c, 7.5%-10%
- •Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
- •FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
- •Willingness to accept, and ability to inject insulin Glargine therapy
排除标准
- •Pregnancy : The use of LANTUS & APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
研究组 & 干预措施
1
Experimental
combination of insulin Glargine & insulin Glulisine as basal bolus regimen
干预措施: insulin glulisine (Drug)
1
Experimental
combination of insulin Glargine & insulin Glulisine as basal bolus regimen
干预措施: insulin glargine (Drug)
结局指标
主要结局
Evaluating the Glycemic control of the regimen : Change in A1C levels
时间窗: from baseline to study end
次要结局
- Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?(from baseline to study end)
研究者
研究点 (2)
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