NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,030
- 试验地点
- 1
- 主要终点
- Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
研究概览
简要总结
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.
All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.
The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.
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 2 diabetes mellitus
- •Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
- •HbA1c: 7.0-10.0%
- •Body Mass Index (BMI) no higher than 40.0 kg/m^2
- •For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)
排除标准
- •Treatment with exenatide or liraglutide within the last 3 months before trial start
- •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
- •Cancer and medical history of cancer
研究组 & 干预措施
IDeg OD
干预措施: insulin degludec (Drug)
IGlar OD
干预措施: insulin glargine (Drug)
结局指标
主要结局
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 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.
Extension Trial (Primary Endpoint): Rate of Nocturnal 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. Nocturnal hypoglycaemic episodes are 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 104 + 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 52 + 7 days follow up)
- Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment(Week 0, Week 104)
- Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52(Week 52)
- Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104(Week 104)
- Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 52 + 7 days follow up)