NCT01831765已完成3 期
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults 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
- 1,290
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.
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
- Double (Participant, Investigator)
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 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2
排除标准
- •Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
研究组 & 干预措施
Meal time FIAsp and insulin detemir
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Meal time FIAsp and insulin detemir
Experimental
干预措施: insulin detemir (Drug)
Meal time insulin aspart and insulin detemir
Active Comparator
干预措施: insulin detemir (Drug)
Meal time insulin aspart and insulin detemir
Active Comparator
干预措施: insulin aspart (Drug)
Post meal FIAsp and insulin detemir
Experimental
干预措施: insulin detemir (Drug)
Post meal FIAsp and insulin detemir
Experimental
干预措施: Faster-acting insulin aspart (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, week 26
Change from baseline in HbA1c after 26 weeks of randomised treatment.
次要结局
- Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)(Week 0, week 26)
- Change From Baseline in HbA1c (Post Meal Arm)(Week 0, week 26)
- Number of Treatment Emergent Confirmed Hypoglycaemic Episodes(From baseline until week 26)
- Change From Baseline in Body Weight(Week 0, week 26)
- Frequency of Adverse Events(After 52 weeks of randomised treatment)
- Change in HbA1c(Week 0, week 52)
- Change in PPG (Postprandial Glucose)(Week 0, week 52)
研究者
研究点 (1)
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