NCT00115973已完成1 期
An Open-Label, Stepwise Basal Insulin Dose Titration Study Using Continuous Subcutaneous Insulin Infusion (CSII) in Oral Antidiabetic Drug-Treated Type 2 Diabetes Mellitus Subjects Followed by a 10-Week Out-Patient Maintenance Phase
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 7
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the final clinic visit. A subject's participation in this trial would be expected to be up to 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosis at least 2 years ago
- •Body Mass Index (BMI): 26-40 kg/m^2 (both inclusive)
- •HbA1c: 7.5-10% (both inclusive)
- •FPG values at least 140 mg/dl (7.8 mmol/l)
排除标准
- •Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization (steroids or non-specific beta-blockers)
- •Current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use
- •Known or suspected allergy to trial products or related products
结局指标
主要结局
HbA1c
时间窗: after 3 months
次要结局
- Fasting plasma glucose
- Plasma glucose profiles
- Frequency of hypoglycemic events
研究者
研究点 (7)
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