A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin degludec, both with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes treated with basal insulin - ONWARDS 2

ovo Nordisk A/S0 个研究点目标入组 520 人开始时间: 2021年1月4日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•- Male or female aged above or equal to 18 years at the time of signing informed consent.
•- Diagnosed with T2D at least 180 days prior to the day of screening.
•- HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
•- Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL): at least 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses at least 90 days prior to screening:
•- Metformin
•- Sulfonylureas
•- Meglitinides (glinides)
•- Dipeptidyl peptidase-4 (DPP-4) inhibitors
•- Sodium-glucose Co-transporter-2 (SGLT2) inhibitors
•- Thiazolidinediones
•- Alpha-glucosidase inhibitors
•- Oral combination products (for the allowed individual oral anti-diabetic drugs)
•- Oral or injectable glucagon like peptides 1 (GLP-1)-receptor agonists
•- Body mass index (BMI) equal to or below 40.0 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 312
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 208

•- Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
•- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
•- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
•- 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).
•- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

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