EUCTR2020-000476-38-DE进行中（未招募）1 期
Effectiveness and safety of once weekly insulin icodec used with DoseGuide versus once daily basal insulin analogues in an insulin naïve type 2 diabetes population in a clinical practice setting - ONWARDS 5
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,096
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 for the trial.
- •- Male or female.
- •- Age above or equal to 18 years at the time of signing informed consent.
- •- Diagnosed with T2D 180 days or more prior to the day of screening.
- •- Glycosylated haemoglobin (HbA1c) above 7.0% (53 mmol/mol) as measured by central lab.
- •- Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- •- Stable daily dose(s) 90 days or more prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s):
- •a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose.
- •b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose.
- •c. Any of the following non-insulin antidiabetic drug classes including combinations (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose):
- •i. Sulfonylureas
- •ii. Meglitinides (glinides)
- •iii. Dipeptidyl peptidase 4 (DPP-4) inhibitors
- •iv. Sodium-glucose cotransporter-2 (SGLT2) inhibitors
- •v. Thiazolidinediones
- •vi. Alpha-glucosidase inhibitors
- •vii. Oral combination products (for the allowed individual Oral Antidiabetic
- •Drugs (OADs))
- •viii. Oral or injectable glucagon-like protein-1 (GLP-1)-receptor agonists
- •8. Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 713
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 383
排除标准
- •- Known or suspected hypersensitivity to trial product(s) or related products.
- •- Previous participation in this trial. Participation is defined as signed informed consent.
- •- 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).
- •- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or nonapproved 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).
- •- Any disorder which in the investigator’s opinion might jeopardise subject’s safety.
研究者
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