Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® both in Combination with Insulin Degludec with or without Metformin in Adults with Type 2 Diabetes - onset® 9

ovo Nordisk A/S0 个研究点目标入组 1,262 人开始时间: 2017年7月13日最近更新: 2019年4月30日

适应症

试验速览

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•- Male or female, age = 18 years at the time of signing informed consent.
•- Diagnosed with type 2 diabetes = 10 years prior to screening (Visit 1).
•- Treated with a basal-bolus insulin regimen = 1 year prior to the day of screening (Visit 1). A
•basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin
•analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble
•insulin combination is not considered a basal-bolus regimen.
•- Treated with or without oral antidiabetic drugs including extended release formulations.
•- HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1).
•Randomisation criterion:
•- HbA1c = 9.0% measured by the central laboratory at Visit 13 (week -1).
•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 965
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 107

•- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1).
•- Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
•- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1).
•- Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1).
•- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).

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