NCT07112339招募中4 期
EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 586
- 试验地点
- 145
- 主要终点
- Change in glycated haemoglobin (HbA1c)
研究概览
简要总结
This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
- •Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening:
- •Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.
- •Need of intensification with basal insulin, as indicated at the discretion of the investigator.
- •Recorded HbA1c value ≥7% within the last 90 days prior to randomization.
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 child-bearing potential and not using adequate contraceptive method.
- •Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
- •Any disorder which in the investigator's opinion might jeopardize participant's safety.
研究组 & 干预措施
Insulin icodec
Experimental
Participants will receive subcutaneous (s.c) injection of once weekly insulin icodec.
干预措施: Insulin icodec (Drug)
Basal insulin analogues
Active Comparator
Participants will receive once daily s.c. injection of basal insulin analogues.
干预措施: Basal insulin analogues (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: From baseline week 0 to week 52
Measured as %-point.
次要结局
- Adelphi Adherence Questionnaire (ADAQ©)(At week 52)
- Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction(From baseline week 0 to week 52)
- Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain(At week 52)
- Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain(At week 52)
- Number of severe hypoglycaemic episodes (level 3)(From baseline week 0 to week 52)
- Mean weekly basal insulin dose(From week 50 to week 52)
- Participant achieved individualised HbA1c target(At week 52)
研究者
研究点 (145)
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