EUCTR2008-005774-13-FR进行中（未招募）1 期
A 52 week randomised, controlled, open label, multicentre, multinational, parallel, treat-to-target trial comparing efficacy and safety of SIBA and insulin glargine both administered once daily in a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 standard management of the
- •2. Males or females, = 18 years of age.
- •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
- •1. 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 event 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 Germany: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner)(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 or participation in other trials within one month prior to screening visit (Visit 1)
- •17. Known or suspected abuse of alcohol, narcotics or illicit drugs
研究者
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