NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 456
- 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 Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with insulin detemir (IDet), both combined with insulin aspart.
The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.
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%
- •Body Mass Index (BMI) below or equal to 35.0 kg/m^2
- •For Japan only: Minimum age is 20 years
- •For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)
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
- •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)
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 Treatment Emergent Adverse Events (AEs)
时间窗: Week 0 to Week 52 + 7 days follow up
Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/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 or important medical issues
次要结局
- Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment(Week 0, Week 52)
- Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment(Week 0, Week 52)
- Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26(Week 26)
- Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52(Week 52)
- Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 52 + 7 days follow up)
- Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment(Week 0, Week 26)
- Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
- Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
- Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 52 + 7 days follow up)