EUCTR2009-011672-29-IT进行中（未招募）不适用
A trial investigating the efficacy and safety of NN1250 compared to insulin detemir in subjects with type 1 diabetes mellitus in a basal/bolus treatment regimen - BEGIN : BB T1
OVO NORDISK0 个研究点目标入组 426 人开始时间: 2009年12月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 426
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. Males or females, ≥ 18 years of age (≥ 20 years for Japan) 3. Type 1 diabetes mellitus (diagnosed clinically) ≥ 12 months 4. Current treatment with any basal/bolus insulin regimen for at least 12 months prior to Visit 1 5. HbA1c ≤ 10.0 % by central laboratory analysis 6. BMI ≤ 35.0 kg/m2 7. Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles according to the protocol
- •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
- •Use within the last 3 months prior to Visit 1 of any other antidiabetic glucose lowering drug than insulin 2. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors 3. Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)2 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty 4. Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥ 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure ≥ 100 mmHg) 5. Impaired liver function, defined as ALAT ≥ 2.5 times upper limit of normal (one re-test analysed at the central laboratory within a week from receipt of the result is permitted with the result of the last sample being conclusive) 6. Impaired renal function defined as serum-creatinine ≥ 180 μmol/L (≥ 2.0 mg/dl); one re-test within a week from receipt of the result is permitted. Last sample will be conclusive 7. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during the last 12 months) or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months 8. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator 9. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for 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) 10. Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer) 11. Any clinically significant disease or disorder, except for conditions associated with type 1 diabetes, which in the Investigator s opinion could interfere with the results of the trial 12. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write 13. 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 14. Known or suspected allergy to any of the trial products or related products 15. Receipt of any investigational drug within one month prior to screening visit (Visit 1) 16. Donation of blood within one month prior to screening visit (Visit 1) 17. Participation in other trials within one month prior to screening visit (Visit 1). For Brazil only: receipt of any investigational drug within one year prior to screening visit (visit 1), unless there is a direct benefit to the research subject at the investigator`s discretion 18. Known or suspected abuse of alcohol, narcotics or illicit drugs 19. Previous treatment with insulin 454 20. Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
研究者
相似试验
进行中（未招募）
不适用
A trial investigating the efficacy and safety of NN1250 compared to insulin detemir in subjects with type 1 diabetes mellitus in a basal/bolus treatment regimetype 1 diabetes mellitusEUCTR2009-011672-29-FIovo Nordisk A/S426
已完成
3 期
Comparison of NN1250 plus insulin Aspart with insulin Detemir plus insulin Aspart in type 1 diabetes.CTRI/2010/091/000145ovo Nordisk AS60
进行中（未招募）
1 期
A trial investigating the efficacy and safety of NN1250 compared to insulin detemir in subjects with type 1 diabetes mellitus in a basal/bolus treatment regimeMedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitustype 1 diabetes mellitusEUCTR2009-011672-29-GBovo Nordisk A/S
进行中（未招募）
不适用
A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitusDiabetes Mellitus, Type 1EUCTR2012-003566-41-BEovo Nordisk A/S346
进行中（未招募）
不适用
A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitusDiabetes Mellitus, Type 1MedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861EUCTR2012-003566-41-SIovo Nordisk A/S346