EUCTR2011-001712-61-BG进行中（未招募）不适用
A 26-week, randomised, open-label, multinational, treat-to-target trial comparing efficacy and safety of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) and BIAsp 30 BID both with metformin in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled on metformin monotherapy or metformin in combination with one additional oral antidiabetic drug (OAD). - BOOST™
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
- 394
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
- •- 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.)
- •- Male or female = 18 years of age
- •- Type 2 diabetes mellitus (diagnosed clinically) for = 24 weeks
- •- Current treatment: metformin monotherapy or metformin in any combination with one of the following OADs: insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPPIV) inhibitor, a-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated:
- •- Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily)
- •- Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling
- •- DPP-IV inhibitor: minimum 100 mg daily or according to local labelling
- •- a-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
- •- Insulin naïve subject; allowed is:
- •- Previous short term insulin treatment up to 14 days
- •- Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
- •- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- •- Body mass index (BMI) = 40.0 kg/m2
- •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 319
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •- Treatment with thiazolidinedione (TZDs) or GLP-1 receptor agonists within 12 weeks prior to Visit 1
- •- Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
- •- Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
- •- Cardiovascular disease, within the last 24 weeks prior to visit 1, defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- •- Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial
- •- 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
- •- Known or suspected hypersensitivity to trial products or related products
研究者
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