A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
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 compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects 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
- 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
- •Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypo episode within the last year (according to the ADA (American Diabetes Association) definition, April 2013) b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (chronic kidney disease epidemiology collaboration) c) Hypoglycaemic symptom unawareness d) Diabetes mellitus duration for more than 15 years e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Male or female, age at least 18 years at the time of signing informed consent - Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 - Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH) insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4 daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin) for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2
排除标准
- •Treatment with IGlar or IDeg within the last 26 weeks prior to Visit 1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior to screening) - Use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1
研究组 & 干预措施
IDeg OD + IAsp followed by IGlar OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
干预措施: insulin degludec (Drug)
IDeg OD + IAsp followed by IGlar OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
干预措施: insulin glargine (Drug)
IDeg OD + IAsp followed by IGlar OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
干预措施: insulin aspart (Drug)
IGlar OD + IAsp followed by IDeg OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
干预措施: insulin degludec (Drug)
IGlar OD + IAsp followed by IDeg OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
干预措施: insulin glargine (Drug)
IGlar OD + IAsp followed by IDeg OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
干预措施: insulin aspart (Drug)
结局指标
主要结局
Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
时间窗: A 16-week treatment period.
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).
次要结局
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period(After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64))
- Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period(After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64))
- Incidence of Treatment Emergent Adverse Events(During 32 weeks of treatment for each treatment period)
- Change From Baseline in HbA1c (Glycosylated Haemoglobin)(Week 32, Week 64)
- FPG (Fasting Plasma Glucose)(Week 32 and Week 64)