A 26-week, randomised, open-label, multinational, treat-to-target trialcomparing efficacy and safety of insulin degludec/insulin aspart once daily(OD) and insulin glargine OD both in combination with metformin ininsulin-naïve subjects with type 2 diabetes inadequately controlled on oralantidiabetic drugs (OADs) - BOOST™ : START 2

ovo Nordisk A/S0 个研究点目标入组 795 人开始时间: 2010年12月14日最近更新: 2013年10月7日

适应症

试验速览

暂无简介。

•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 = 6 months
•HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis
•BMI = 40.0 kg/m^2
•Insulin naïve subjects (Allowed are: Previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
•Ongoing treatment with: Metformin with or without other OAD for at least 3 months prior to randomisation with the minimum metformin dose of 1500 mg daily or maximum tolerated dose (at least 1000 mg daily).
•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

•Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
•Use within 3 months prior to Visit 1 of GLP-1 receptor agonist and/or TZDs
•Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke;
•decompensated heart failure New York Heart Association (NYHA)3 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty.

发起方