CTIS2022-502484-38-00招募中1 期
A 40-week study comparing the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL in participants with type 2 diabetes inadequately controlled on oral anti diabetic drugs. COMBINE 4 - NN1535-4988
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 474
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 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 18 years or above at the time of signing the informed consent., Diagnosed with type 2 diabetes mellitus = 180 days before screening., HbA1c = 8.0% (= 64.0 mmol/mol) as assessed by central laboratory on the day of screening., Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes., Currently treated with 1-3 OADs with stable daily doses = 90 days before screening comprising any of the following anti-diabetic drug(s) at effective or maximum tolerated dose (a): Metformin, Sulfonylureasa (b), Meglitinides (glinides) (b), DPP 4 inhibitors (b), Sodium glucose co transporter 2 inhibitors, Alpha glucosidase inhibitors, Thiazolidinediones, Marketed oral combination products only including the products listed above. a) As per investigator judgement participant is suitable for intensification with injectables. b) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation., Body mass index (BMI) = 40.0 kg/m2.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products., Presence or history of pancreatitis (acute or chronic) within 180 days before screening.(c) c) For Turkey, stricter exclusion criteria applies Presence or history of pancreatitis (acute or chronic)” , see Appendix 16 (Section ??10.16), 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., Impaired liver function, defined as alanine aminotransferase = 2.5 times or bilirubin > 1.5 times upper normal limit at screening., Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8., 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 Section ?8.2.5., Previous participation in this study. Participation is defined as signed informed consent., 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., For Italy, an additional exclusion criteria known severe diabetic autonomic neuropathy as judged by the investigator” is applicable, please see protocol Appendix 16 (Section ?10.16), Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method, as defined in Appendix 4 (Section ?10.4)., Participation (defined as 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.(a) a) not applicable for Japan and China, 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 episodes(b) of diabetic ketoacidosis within 90 days before screening. b) as declared by the part
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