NCT01680341已完成3 期
A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)
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
- 272
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
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 the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.
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 (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
- •Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
- •Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
- •Body mass index (BMI) below or equal to 40 kg/m^2
排除标准
- •Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
- •Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
- •Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
- •Life-threatening disease (e.g. cancer)
研究组 & 干预措施
IDegAsp Simple
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
IDegAsp Step wise
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
时间窗: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, Week 26)
- Subjects With HbA1c Below 7.0%(Week 26)
- Number of Treatment Emergent Confirmed Hypoglycaemic Episodes(Weeks 0-27)
- Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period(From week 16 to end of trial including follow-up (week 27))
- Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes(Weeks 0-27)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Weeks 0-28)
- Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia(Week 26)
研究者
研究点 (1)
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