NCT00634842已完成4 期
Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
研究概览
简要总结
This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •1-3 oral treatments
- •Insulin naive
- •BMI (Body Mass Index) less than or equal to 45
排除标准
- •Pregnancy
- •Retinopathy
- •Cardiac disease
- •Uncontrolled hypertension
- •Recurrent hypoglycaemia
研究组 & 干预措施
FPG 70-90 mg/dL
Experimental
Aggressive FPG (fasting plasma glucose) titration target range group
干预措施: insulin detemir (Drug)
FPG 80-110 mg/dL
Experimental
Conventional FPG (fasting plasma glucose) titration target range group
干预措施: insulin detemir (Drug)
结局指标
主要结局
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
时间窗: week 20
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
次要结局
- Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline(week -2, week 20)
- Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%(week 20)
- Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)(weeks 0-20)
研究者
研究点 (1)
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