EUCTR2010-018974-19-SI进行中（未招募）不适用
A randomised, controlled, open label, multicentre, multinational, treat-to-target trial investigating the efficacy and safety of intensification with addition of bolus insulin aspart in subjects with type 2 diabetes inadequately controlled on basal insulin with or without oral anti-diabetic drugs: Step-wise addition versus complete basal-bolus therapy - Full STEP™
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
- 848
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
- •Male or female =18 years of age
- •Type 2 diabetes (diagnosed clinically) for =12 months
- •Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or insulin detemir once daily) = 6 months
- •HbA1c 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
- •BMI < 40.0 kg/m^2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin only in case of a hospitalisation or a severe condition requiring intermittent use of bolus insulin for less than 14 consecutive days, but not during the last 6 months prior to screening visit (Visit 1)
- •Use of GLP-1 receptor agonists or pramlintide within the last 6 months prior to screening visit (Visit 1)
- •Anticipated change in concomitant medication known to interfere significantly with glucose metabolism (e.g. systemic corticosteroids, beta-blockers, MAO inhibitors, etc.)
- •Cardiovascular disease, within the last 12 months prior to screening visit (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 sitting = 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure = 100 mmHg). For Argentina: systolic blood pressure sitting = 150 mmHg and/or diastolic blood pressure = 90 mmHg
- •Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive).
- •Impaired renal function defined as serum creatinine >135 µmol/L (>1.5 mg/dL) for males and >110 µmol/L ( >1.2 mg/dL) for females; and, if required by the locally applicable metformin label, glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula). One retest within a week is permitted with the result of the last sample being conclusive.
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months.
- •Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
- •Treatment with OADs contraindicated or unapproved for combination treatment with insulin (according to local OAD label)
研究者
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