A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes - NN1436-7724

ovo Nordisk A/S0 个研究点目标入组 404 人开始时间: 2023年11月23日最近更新: 2024年7月22日

适应症

试验速览

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•Diagnosed with T2D =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 U/mL, or insulin glargine 300 U/mL) = 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses = 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, oral combination products (for the allowed individual oral anti-diabetic drugs), oral or injectable GLP-1 RAs, Injectable GLP-1/GIP RA combination products, Body mass index (BMI) = 40.0 kg/m2.

•Any episodes 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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