NCT01570751已完成3 期
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
- •Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
- •Glycosylated haemoglobin (HbA1c) equal to or above 7.5%
排除标准
- •Current treatment with insulin other than insulin glargine in vials
- •Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
- •Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
- •Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)
研究组 & 干预措施
IDeg followed by IGlar
Experimental
干预措施: insulin degludec (Drug)
IDeg followed by IGlar
Experimental
干预措施: insulin glargine (Drug)
IGlar followed by IDeg
Experimental
干预措施: insulin degludec (Drug)
IGlar followed by IDeg
Experimental
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
时间窗: Week 0, week 16 of each treatment period.
Values for change in HbA1c after each 16 weeks of treatment periods A and B.
次要结局
- Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period(Week 0, week 16 of each treatment period.)
- Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B(Week 16, week 20)
- Number of Adverse Events (AEs)(From baseline to the end of each 16 week treatment period.)
- Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period(Week 0, week 16, week 32)
- Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B(Week 16, week 20)
研究者
研究点 (1)
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