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

ovo Nordisk A/S0 个研究点目标入组 0 人开始时间: 2010年3月15日最近更新: 2019年11月25日

研究概览

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•Males or females, age = 18 years (= 20 years for Japan)
•Type 1 diabetes mellitus (diagnosed clinically) = 12 months
•Current treatment with any basal/bolus insulin regimen for at least 12 months prior to visit 1
•HbA1c = 10 % by central laboratory analysis
•BMI = 35.0 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

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

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