NCT01272193已完成3 期
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)
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
- 296
- 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 Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.
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
- 20 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
- •HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
- •Body Mass Index (BMI) below or equal to 35.0 kg/m^2
- •Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
排除标准
- •Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
- •Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
- •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
研究组 & 干预措施
IDegAsp OD
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
IDegAsp OD
Experimental
干预措施: insulin glargine (Drug)
IGlar OD
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, Week 26
Observed change from baseline in HbA1c after 26 weeks of treatment
次要结局
- Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal(Week 26)
- Rate of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 26 + 7 days follow up)
- 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)
- Change in Body Weight(Week 0, Week 26)
研究者
研究点 (1)
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