NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational 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 ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,006
- 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 Africa, Asia, Europe, and the United States of America (USA).
The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.
All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.
Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.
The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.
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 MAIN period (NN1250-3582):
- •Type 2 diabetes mellitus for at least 6 months
- •Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
- •HbA1c 7.0-10.0 % (both inclusive)
- •Body Mass Index (BMI) below or equal to 40.0 kg/m^2
- •For EXTENSION period (NN1250-3667):
- •Completion of the 52 week treatment period in NN1250-3582
排除标准
- •For MAIN period (NN1250-3582):
- •Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus 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
- •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
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 78 + 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 78 + 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.
Rate of Treatment Emergent Adverse Events (AEs)
时间窗: Week 0 to Week 78 + 7 days follow up
Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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
- Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment(Week 0, Week 78)
- 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)
- Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78(Week 78)
- Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 52 + 7 days follow up)