CTRI/2021/08/035474进行中（未招募）3 期
A 26-week, randomised, multicentre, open-label, active-controlled, parallel group, two armed,treat-to-target trial investigating the effect on glycaemic control and safety of treatment with onceweekly Insulin Icodec compared to once daily Insulin Degludec, both in combination with InsulinAspart in adults with type 1 Diabetes, with a 26-week extension investigating long term safety. - ONWARDS 6
ovo Nordisk ASNovo All0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any
- •procedures that are carried out as part of the trial, including activities to determine suitability forthe trial.
- •2. Male or female aged >=18 years at the time of signing informed consent.
- •3. Diagnosed with type 1 diabetes mellitus >= 1 year prior to the day of screening.
- •4. Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) >= 1year prior to the day of screening.
- •5. HbA1c <10% at screening visit measured by central laboratory.
排除标准
- •1.Known or suspected hypersensitivity to trial products or related products.
- •2. Previous participation in this trial. Participation is defined as signed informed consent.
- •3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
- •potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- •4. Participation in any clinical trial of an approved or non-approved investigational medicinal
- •product within 90 days before screeninga.
- •5. Any disorder, except for conditions associated with T1D which in the investigatorâ??s opinion
- •might jeopardise subjectâ??s safety or compliance with the protocol.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, orcorticosteroids).
- •7. Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- •8. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at
- •9. Planned coronary, carotid or peripheral artery revascularisation.
- •10. Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of
- •<30 ml/min/1.73m2 at screening measured by central laboratory.
- •11. Impaired liver function, defined as Alanine Aminotransferase (ALT) >=2.5 times or
- •Bilirubin >1.5 times upper normal limit at screening measured by central laboratory.
- •12. Known hypoglycaemic unawareness as indicated by the investigator according to Clarkeâ??s
- •questionnaire question 8.17
- •13. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- •14. Inadequately treated blood pressure defined as systolic >=180 mmHg or diastolic >=110 mmHg at screening.15. 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.
- •16. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening.
- •17. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening.
研究者
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