NCT00349986终止4 期
The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- HgbA1c measurement
研究概览
简要总结
The rationale of the study is to determine:
- the first dose and the titration of basal insulin
- the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
- •Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
- •BMI >25 kg/m2 , <30 kg/m2
- •HbA1c value >7.0%, <9.0% within one month
排除标准
- •Type 1 Diabetes Mellitus
- •Known malignancy
- •Drug or alcohol abuse
- •Severe liver disease
- •Renal failure (se Creatinine > 150 micro mol/l)
- •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
HgbA1c measurement
次要结局
未报告次要终点
研究者
研究点 (1)
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