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

Novo Nordisk India Private Limited13 个研究点分布在 1 个国家目标入组 404 人开始时间: 2024年6月20日最近更新: 2024年11月13日

试验速览

阶段: 3 期
状态: 招募中
发起方: Novo Nordisk India Private Limited
入组人数: 404
试验地点: 13
主要终点: To demonstrate the effect on glycaemic

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an interventional, multi-national, multi-centre, randomised, parallel-group, treat-to-target, open-label, active-comparator study.

This is a 26-week study designed to investigate the effect on glycaemic control, safety and patient reported outcomes (PROs) of once-weekly insulin icodec, switched unit-to-unit from a daily basal insulin, versus once-daily insulin glargine U100, both treatment arms with or without non-insulin anti-diabetic drugs, in adults with type 2 diabetes (T2D) treated with basal insulin.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•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 re-gimens 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.

排除标准

•Known or suspected hypersensitivity to study intervention(s) or related products.
•Previous participation in this study.
•Participation is defined as signed informed consent.
•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4).
•Participation (i.e., signed informed consent) in any interventional clinical study within 90 daysbefore screening.
•Note: Simultaneous participation in a study with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening in the current study.
•Any disorder, except for conditions associated with T2D, which in the investigatorâ€™s opinion might jeopardise participantâ€™s safety or compliance with the protocol.
•Any episodesa 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.
•Planned coronary, carotid or peripheral artery revascularisation.
•Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m2 at screening by central laboratory analysis.
•Impaired liver function, defined as Alanine Aminotransferase â‰¥ 2.5 times or Bilirubin >1.5 times upper normal limit at screening.
•Known hypoglycaemic unawareness as indicated by the investigator according to Clarkeâ€™s questionnaire question 8 (Section 8.2).
•Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
•Inadequately treated blood pressure defined as systolic â‰¥180 mmHg or diastolic â‰¥110 mmHg 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 (V1) and until the start of runin (V2).
•Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
•Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia [PIN]) within 5 years before screening.
•Anticipated change in lifestyle affecting glucose control (e.g., eating, exercise or sleeping pattern) during the study.
•Use of any medication with unknown or unspecified content within 90 days prior to the day of Screening.