EUCTR2004-001461-18-ES进行中（未招募）1 期
A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to oral antidiabetic drug(s) in subjects with type 2 diabetes
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 2005年11月3日最近更新:
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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.Type 2 diabetes according to clinical judgement.
- •3.Duration of type 2 diabetes =12 months.
- •4.Insulin naïve subjects. Previous short-term insulin treatment (seven days or less) is allowed.
- •5. Currently on any oral antidiabetic drug (OAD) = 3 months according to the following:
- •Countries where the combination of insulin and TZD is not approved:
- •? OAD monotherapy, except TZD or alpha-glucosidase inhibitors
- •? OAD combination therapy, except the combination of TZD and alpha-glucosidase inhibitors
- •Countries where the combination of insulin and TZD is approved:
- •? Any OAD treatment except monotherapy with alpha-glucosidase inhibitors
- •6. The dose of the individual OAD must be either highest tolerated dose or at least half maximum recommended dose according to local labelling = 3 months prior to screening.
- •7. The OAD dose(s) must be unchanged for the last month prior to screening.
- •8. Age = 18 years, females and males.
- •9. Body mass index (BMI) = 40.0 kg/m2.
- •10. HbA1c = 7.5 and =11.0% at screening based on analysis from the central laboratory.
- •11. Able and willing to use daily injections of insulin for the entire trial period.
- •12. Able and willing to perform self-monitoring of plasma glucose according to the protocol
- •Are the trial subjects under 18?
- •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.Previous participation in this trial. Participation is defined as screened.
- •2.Previous acute treatment with insulin > 7 days.
- •3.Treatment with TZD and/or other OAD(s) which does not adhere to the approved labelling for the respective country.
- •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.Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator.
- •7.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.
- •8.Uncontrolled hypertension (treated or untreated) as judged by the investigator.
- •9.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
- •10.Known or suspected allergy to trial product(s) or related products.
- •11.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. In Denmark and France barrier methods are not accepted as adequate contraceptives.
- •12.The receipt of any investigational drug within one month prior to this trial.
- •13.Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
研究者
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