CTRI/2022/01/039705已完成3 期
A 52 week study comparing the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL combined with insulin aspart, both treatment arms with or without oral anti diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily basal insulin.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novo Nordisk
- 入组人数
- 680
- 试验地点
- 13
- 主要终点
- Change in HbA1c - % point
研究概览
简要总结
This is an interventional, multi-national, multi-centre, randomised, 52-week, open label, parallel
group, treat-to-target, confirmatory study with two treatment arms.This study is designed to investigate the efficacy and safety of once weekly IcoSema, which is a combination product of insulin icodec and semaglutide. IcoSema will be compared to daily insulin glargine 100 units/mL combined with insulin aspart, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily basal insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent obtained before any study-related activities.
- •Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female.
- •Age above or equal to 18 years at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- •HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- •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) 20-80 units/day ≥ 90 days before screening.
- •Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes.
- •The treatment can be with or without any of the following anti-diabetic drugs with stable doses ≥ 90 days before screening: â–ª Metformin â–ª Sulfonylureasa â–ª Meglitinides (glinides)a â–ª DPP4 inhibitorsa â–ª Sodium-glucose co-transporter 2 inhibitors â–ª Alpha-glucosidase-inhibitors â–ª Thiazolidinediones â–ª Marketed oral combination products only including the products listed above.
- •Body mass index (BMI) ≤ 40.0 kg/m2 .
- •Not currently using real time continuous or flash glucose monitoring.
排除标准
- •Known or suspected hypersensitivity to randomised treatment 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 a highly effective contraceptive method, as defined in Appendix
- •Participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before 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 and if simultaneous participation is allowed by local authorities.
- •Any disorder, except for conditions associated with T2D, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- •Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- •Any episodesa of diabetic ketoacidosis within 90 days before screening.
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
- •Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before 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 measured as estimated glomerular filtration rate value of < 30 ml/min/1.73 m2 at screening as defined by KDIGO 2012.27
- •Impaired liver function, defined as alanine aminotransferase ≥ 2.5 times or bilirubin > 1.5 times upper normal limit at screening.
- •Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
- •Inadequately treated blood pressure defined as systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg at screening.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •Verified by a fundus examination performed within the past 90 days before 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, see 8.2.
- •Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in situ prostate cancer) within 5 years before screening.
结局指标
主要结局
Change in HbA1c - % point
时间窗: From baseline week 0 (V2) to week 52 (V54)
次要结局
- "Change in body weight - in KG(")
- Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)(From baseline week 0 (V2) to week 57 (V56))
- Weekly insulin dose (total)(From week 50 (V52) to week 52 (V54))
- Time in range 3.9-10.0 mmol/L (70-180 mg/dL)(From week 48 (V50) to week 52 (V54))
- Time spent 3.0 mmol/L (54 mg/dL)(From week 48 (V50) to week 52 (V54))
- Time spent 10.0 mmol/L (180 mg/dL)(From week 48 (V50) to week 52 (V54))
- Change in fasting plasma glucose (FPG) - in mmol/L(From baseline week 0 (V2) to week 52 (V54))
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction(From baseline week 0 (V2) to week 52 (V54))
- Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter)(From baseline week 0 (V2) to week 57 (V56))
- Number of severe hypoglycaemic episodes (level 3)(From baseline week 0 (V2) to week 57 (V56))
研究者
研究点 (13)
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