NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 629
- 试验地点
- 1
- 主要终点
- Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin
研究概览
简要总结
This trial is conducted in Africa, Europe and the United States of America (USA).
The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.
The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.
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
- •Type 1 diabetes mellitus for at least 12 months
- •Current treatment with any basal bolus insulin for at least 12 months
- •HbA1c below or equal to 10.0%
- •BMI (Body Mass Index) below or equal to 35.0 kg/m^2
- •For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)
排除标准
- •Use of any other antidiabetic drug than insulin within the last 3 months
- •Cardiovascular disease within the last 6 months
- •Uncontrolled treated/untreated severe hypertension
- •Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- •Cancer and medical history of cancer
研究组 & 干预措施
IDeg OD
干预措施: insulin degludec (Drug)
IDeg OD
干预措施: insulin aspart (Drug)
IGlar OD
干预措施: insulin glargine (Drug)
IGlar OD
干预措施: insulin aspart (Drug)
结局指标
主要结局
Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin
时间窗: Week 0, Week 106
The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
时间窗: Week 0, Week 52
Change from baseline in HbA1c after 52 weeks of treatment
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
时间窗: Week 0 to Week 104 + 7 days 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.
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
时间窗: Week 0 to Week 104 + 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
次要结局
- Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment(Week 0, Week 104)
- Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment(Treatment week 104)
- Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 104 + 7 days follow up)
- Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 52 + 7 days follow up)
- Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 52 + 7 days follow up)
- Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52(Week 52)