A trial comparing the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart in subjects with type 2 diabetes mellitus previously treated with insulin glargine - BOOST®: SIMPLE vs. STEPWISE

ovo Nordisk A/S0 个研究点目标入组 270 人开始时间: 2012年5月25日最近更新: 2014年3月24日

适应症

试验速览

暂无简介。

•- Age = 18 years
•- Type 2 diabetes (diagnosed clinically) for = 24 weeks prior to Visit 2 (randomisation)
•- Currently treated with IGlar and up to 3 OADs (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor) - All antidiabetic treatments should have been ongoing for =12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
•- HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
•- Body mass index (BMI) = 40 kg/m^2
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
•- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
•- Uncontrolled or untreated severe hypertension defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg
•- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
•- Life-threatening disease (e.g. cancer)

发起方