jRCT2031210076已完成不适用
A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen.(NN1436-4480) (ONWARDS4)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- HbA1c
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female aged above or equal to 18 years at the time of signing informed consent.
- •Diagnosed with T2D>= 180 days prior to the day of screening.
- •HbA1c from 7.0-10.0% (53.0 85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- •Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, insulin glulisine) >= 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses>= 90 days prior to screening:
- •Sulfonylureas
- •Meglitinides (glinides)
- •DPP-4 inhibitors
- •SGLT2 inhibitors
- •Thiazolidinediones
- •Alpha-glucosidase inhibitors
- •Oral combination products (for the allowed individual oral anti-diabetic drugs)
- •Oral or injectable GLP-1-receptor agonists
- •Body mass index (BMI) <= 40.0 kg/m2.
排除标准
- •Any episodesa of diabetic ketoacidosis within 90 days prior to the day of screening.
- •Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- •Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- •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, or corticosteroids).
- •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.
结局指标
主要结局
HbA1c
时间窗: 26 weeks
The difference in change from baseline in HbA1c between insulin icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
1 期
A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin degludec, in people with type 2 diabetes who use daily insuliMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2020-000454-10-BGovo Nordisk A/S520
进行中（未招募）
1 期
A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin degludec, in people with type 2 diabetes who use daily insuliMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2020-000454-10-DEovo Nordisk A/S520
进行中（未招募）
1 期
A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin glargine, both in combination with mealtime insulin, in people with type 2 diabetes who use daily insulin and mealtime insuliMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2020-000474-16-BEovo Nordisk A/S580
已完成
3 期
A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen.(NN1436-4480)type 2 diabetesJPRN-jRCT2031210076ishida Hiroko80
已完成
3 期
A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen.Diabetes Mellitus type 210018424diabetesNL-OMON54981ovo Nordisk40