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

ovo Nordisk India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

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•1 Diagnosed with T2D for more than or equal to 180 days prior to the day of screening.
•2 HbA1c from 7.0 to 10.0 percent (53.0 to 85.8 mmol per mol), both inclusive, at screening confirmed by central laboratory analysis.
•3 Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin,
•insulin degludec, insulin detemir, insulin glargine 100 U per mL, or insulin glargine 300 U per mL) more than or equal to 90 days prior to the day of screening with or without any of the following anti diabetic drugs or regimens with stable doses more than or equal to 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), DPP 4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti diabetic drugs), oral or injectable GLP 1 RAs, injectable GLP 1 or GIP RA combination products.
•4 Body mass index (BMI) less than 40.0 kg per m2.

•1 Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
•2 Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient
•ischaemic attack within 180 days prior to the day of screening.
•3 Chronic heart failure classified as being in New York Heart Association Class IV at
•4 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).
•5 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.

发起方

ovo Nordisk India Private Limited