EUCTR2005-000976-42-ES进行中（未招募）1 期
A multi-centre, open-labelled, randomised, two-group parallel, treat-to-target trial comparing the weight change in overweight and obese subjects with type 2 diabetes after 26 weeks of treatment with insulin detemir once daily versus insulin NPH once daily, both with insulin aspart in the mealtime.(PREDICTIVE-BMI study) - PREDICTIVE-BMI study
ovo Nordisk Pharma S.A.0 个研究点目标入组 0 人开始时间: 2006年5月17日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. 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. Female or male, age =18
- •3. Subjects with type 2 diabetes who have been treated with 2 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion
- •4. HbA1c = 7.5 and = 11% based on analysis from central laboratory
- •5. BMI = 25 kg/m2 and = 40 kg/m2
- •6. Able and willing to perform self-monitoring of blood glucose.
- •7. Willing to accept multidose insulin therapy
- •8. Able to self-inject all required doses of insulin
- •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. Treatment with any OAD (Oral Antidiabetic Drugs), excepting metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period).
- •2. Any disease or condition (such as renal, hepatic or cardiac) that, according to the judgement of the Investigator, makes the subject unsuitable for participation in the trial.
- •3. Total daily insulin dose = 2 IU/kg.
- •4. Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
- •5. Proliferative retinopathy or maculopathy that has required acute treatment within the last six months.
- •6. Uncontrolled hypertension (treated or untreated) as judged by the Investigator
- •7. Known or suspected allergy to trial product(s) or related products.
- •8. Previous participation in this trial. Participation is defined as screened.
- •9. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods.
- •10. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- •11. Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
- •12. Receipt of any investigational drug within 1 month prior to this trial.
研究者
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