EUCTR2006-003288-29-ES进行中（未招募）不适用
Comparación multinacional, abierta, aleatorizada, de grupos paralelos, con un periodo de prueba de 4 semanas y 26 semanas de tratamiento hasta conseguir el objetivo, de insulina aspart bifásica 30 una vez al día frente a insulina glargina una vez al día, ambas en combinación con metformina y con glimepirida, en pacientes con diabetes tipo 2 que no han recibido tratamiento con insulina
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
- 700
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
- •1.Written informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
- •2.Male or female, age =18 years.
- •3.Type 2 diabetes treated with maximum three different types of OADs for more than 6 months.
- •4.Unchanged total daily dose of at least 1500 mg (850 mg for Asian subjects) metformin for at least two months.
- •5.Unchanged total daily dose of at least half maximum recommended daily dose of any insulin secretagogue for the last two months.
- •6.Insulin naïve.
- •7.If treatment with any lipid lowering drug, the treatment (dosage) must have been ongoing and unchanged for at least 2 months.
- •8.HbA1c = 7.0% and = 11.0%.
- •9.BMI = 40.0 kg/m2.
- •10.Able and willing to take 1 s.c. injection a day.
- •11.Able and willing to perform the mandatory SMPG measurements on consecutive days before the visits/phone contacts (weeks prior to Visits 4, 15, 19 and 22: one 9-point profile + additional pre-breakfast measurement; other weeks: three pre-breakfast measurements).
- •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
- •1.Known or suspected allergy to any of the trial products or related products.
- •2.Treatment with any thiazolidinedione (TZD) during the last 5 months before Visit 1 in this trial.
- •3.Known haemoglobinopathy or chronic anaemia or other blood disorder, metabolic or lactic acidosis, hypoxemia, dehydration or cancer (other than basal or squamous cell).
- •4.Cardiac disease, within the last 12 months, defined as: decompensated heart failure (NYHA class III or IV), unstable angina pectoris or myocardial infarction.
- •5.Impaired kidney function with serum creatinine = 135 µmol/L (1.5 mg/dL) for males and = 110 µmol/L (1.3 mg/dL) for females.
- •6.Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in the past 6 months.
- •7. Increased total cholesterol and/or LDL-cholesterol (LDL-C) level more than 2 times the upper reference limit
- •8.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice).
- •9.Proliferative retinopathy or maculopathy requiring acute treatment.
- •10.Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- •11.Any disease or condition which the Investigator feels would interfere with the trial.
- •12.Systemic treatment with any corticosteroid 3 months prior to inclusion.
- •13.Use of any drug (except for OADs required to be included in this investigation), which in the Investigator’s opinion could interfere with glucose levels.
- •14.Previous treatment with insulin for more than 7 days.
- •15.The receipt of any investigational drug within 1 month prior to this trial.
- •16.Previous participation in this trial (participation defined as randomised).
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