NCT01814137已完成3 期
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®: INTENSIFY BID)
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
- 40
- 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 globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).
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
- •HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory
排除标准
- •Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
- •Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
- •Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females
研究组 & 干预措施
IDegAsp BID + IAsp OD
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
IDegAsp BID + IAsp OD
Experimental
干预措施: insulin aspart (Drug)
IDeg OD + IAsp TID
Experimental
干预措施: insulin degludec (Drug)
IDeg OD + IAsp TID
Experimental
干预措施: 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
- Number of Treatment Emergent Hypoglycaemic Episodes(During 26 weeks of treatment)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(During 26 weeks of treatment)
- Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes(During 26 weeks of treatment)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)
研究者
研究点 (1)
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