EUCTR2008-005769-71-DK进行中（未招募）不适用
A 26-week, multinational, multi-centre, open-labelled, two-arm, parallel, randomised, treat-to-target trial comparing efficacy and safety of soluble insulin analogue combination (SIAC) once daily plus meal-time insulin aspart for the remaining meals vs. basal-bolus treatment with insulin detemir plus meal-time insulin aspart in subjects with type 1 diabetes
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
- 528
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 defined as any procedure that would NOT have been performed during normal management of the subject)
- •2. Male or female = 18 years of age
- •3. Type 1 diabetes mellitus (diagnosed clinically) for = 12 months
- •4. Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months prior to Visit 1
- •5. HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- •6. BMI < 35.0 kg/m²
- •7. Ability and willingness to adhere to the protocol including performance of SMPG profiles according to the protocol
- •8. Subject is likely to comply with the Investigators instruction.
- •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 other insulin regimens than those listed in inclusion criterion No. 4 within 3 months prior to Visit 1
- •2. Basal-bolus regimen with basal insulin injected BID
- •3. Use within the last 3 months prior to Visit 1 of any other antidiabetic glucose lowering drug than insulin
- •4. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO) inhibitors
- •5. Anticipated significant lifestyle changes during the trial, shift work (including permanent night/evening shift workers), as well as highly variable eating habits
- •6. Cardiovascular disease, within the last 6 months prior to 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
- •7. Uncontrolled treated/untreated severe hypertension (systolic blood pressure =180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure = 100 mmHg)
- •8. Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the results is permitted with the result of the last sample being conclusive)
- •9. Impaired renal function defined as serum-creatinine =180 µmol/l (= 2 mg/dl ). One retest analysed at the central laboratory within a week of receipt of the results is permitted with the result of the last sample being conclusive
- •10. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •11. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
- •12. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Germany: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner; for United Kingdom (UK): Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
- •13. Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
- •14. Any clinically significant disease or disorder, which in the Investigator’s opinion could interfere with the results of the trial
- •15. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subject not able to read or write
- •16. Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.
- •17. Known or suspected allergy to any of the trial products or related products
- •18. Receipt of any investigational drug within one month prior Visit 1
- •19. Donation of blood or participation in other trials within one month prior to Visit 1.
- •20. Known or suspected abuse of alcohol, narcotics or illicit drugs Subjects randomised in error (not fulfilling the inclusion and/or exclusion criteria) must be
- •withdrawn immediately from the trial.
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