NCT01569841已完成3 期
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
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
- 24
- 试验地点
- 1
- 主要终点
- Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •HbA1c (glycosylated haemoglobin) below or equal to 8.5%
- •Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
- •BMI (body mass index) below 35 kg/m^2
排除标准
- •Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
- •Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
- •Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
- •Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months
研究组 & 干预措施
IDeg
Experimental
干预措施: insulin degludec (Drug)
IGlar
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
时间窗: CGM occured during the last 2 weeks of the 6 weeks treatment period.
Time within the glycaemic target range \[\> 70 mg/dL (3.9 mmol/L) and \< 130 mg/dL (7.2 mmol/L)\] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.
次要结局
- Glycosylated Haemoglobin (HbA1c)(At the end of each 6 week treatment period.)
- Number of Treatment Emergent Confirmed Hypoglycaemic Episodes(Hypoglycemic episodes reported within each 6 week treatment period.)
- Mean Interstitial Glucose (IG) Based on 14 Days of CGM(CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.)
- Fasting Plasma Glucose (FPG)(At the end of each 6 week treatment period.)
- Number of Treatment Emergent Adverse Events (AEs)(Within each week 6 treatment period)
研究者
研究点 (1)
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