NCT01009580已完成3 期
A 26-week, Randomised, Open-labelled, Two-arm, Parallel-group, Treat-to-target Trial Comparing Efficacy and Safety of Soluble Insulin Analogue Combination (SIAC) Twice Daily (BID) With Biphasic Insulin Aspart (BIAsp) 30 BID, With or Without Metformin, With or Without DPP-4 Inhibitor, With or Without Pioglitazone in Subjects With Type 2 Diabetes in Inadequate Glycaemic Control on Once or Twice Daily Premixed or Self-mixed Insulin Regimen With or Without OADs (BOOST™: Intensify Premix 1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.
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 (diagnosed clinically) for at least 6 months
- •Subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (OD) or twice daily (BID), with or without oral antidiabetic drugs) (OADs) (metformin, sulphonylurea (SU), glinides, alpha-glucosidase inhibitor, DPP-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before Visit 1
- •HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- •Body Mass Index (BMI) below or equal to 40.0 kg/m^2
排除标准
- •Treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
- •Treatment with rosiglitazone or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
- •Cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- •Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- •Cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer
研究组 & 干预措施
IDegAsp BID
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
BIAsp 30 BID
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment.
次要结局
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)(Week 26)
- Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
- Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
研究者
研究点 (1)
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