EUCTR2012-003152-37-DE进行中（未招募）不适用
A randomised trial comparing efficacy and safety afterintensification 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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •HbA1c = 7.0% measured after 26 weeks of treatment in NN5401-3941, by central laboratory analysis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- Uncontrolled or untreated severe hypertension defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg
- •- Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) = 2.5 times upper limit of normal
- •- Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females
研究者
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