NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 1
- 主要终点
- Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
研究概览
简要总结
This trial is conducted in Europe, Oceania, and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.
The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.
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
- 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
- •FOR THE MAIN TRIAL, NN5401-3594:
- •Type 1 diabetes mellitus for at least 12 months
- •Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
- •HbA1c 7.0-10.0% (both inclusive)
- •BMI (Body Mass Index) below or equal to 35.0 kg/m^2
- •FOR THE EXTENSION TRIAL, NN5401-3645:
- •The subject must have completed the six-month treatment period in trial NN5401-3594
排除标准
- •FOR THE MAIN TRIAL, NN5401-3594:
- •Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
- •Cardiovascular disease within the last 6 months
- •Uncontrolled treated/untreated severe hypertension
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- •Cancer and medical history of cancer
- •FOR THE EXTENSION TRIAL, NN5401-3645:
- •Anticipated significant lifestyle changes during the trial
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
研究组 & 干预措施
IDegAsp OD
干预措施: insulin degludec/insulin aspart (Drug)
IDegAsp OD
干预措施: insulin aspart (Drug)
IDet
干预措施: insulin detemir (Drug)
IDet
干预措施: insulin aspart (Drug)
结局指标
主要结局
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
时间窗: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
时间窗: Week 0 to Week 53 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
时间窗: Week 0 to Week 53 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
时间窗: Week 0 to Week 53 + 7 days of follow up
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
次要结局
- Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
- Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26(Week 26)
- Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment(Week 0, Week 53)
- Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
- Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment(Week 0, Week 53)