2025-521150-42-00招募中3 期
A 40-week study comparing the efficacy, safety and patient-reported outcomes of once weekly IcoSema and once or twice daily insulin degludec/insulin aspart 100 units/mL, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily pre-mixed insulin. COMBINE 5
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 8
- 主要终点
- Change in HbA1c
研究概览
简要总结
To confirm non-inferiority of once weekly IcoSema versus once or twice daily insulin degludec/insulin aspart, both treatment arms with or without OADs, with respect to glycaemic control measured by change in HbA1c from baseline after 40 weeks in participants with T2D inadequately controlled with pre-mixed insulin treatment using a non-inferiority margin of 0.3%-point.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18 years or above at the time of signing the informed consent.
- •Diagnosed with T2D ≥ 180 days before screening.
- •HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- •Treated with once-daily or twice-daily pre-mixed insulin (containing 25%, 30% or 50% fast/rapid acting component) 20-80 units/day ≥ 90 days before screening. The treatment can be with or without any of the following anti-diabetic drugs with stable daily doses ≥ 90 days before screening: Metformin Sulfonylureas Meglitinides (glinides) DPP-4 inhibitors Sodium-glucose co-transporter 2 inhibitors Alpha-glucosidase-inhibitors Thiazolidinediones Marketed oral combination products only including the products listed above.
- •Body mass index (BMI) ≤ 40.0 kg/m2.
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- •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 of diabetic ketoacidosis within 90 days before screening.
- •Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
- •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.
- •Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
- •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.
结局指标
主要结局
Change in HbA1c
Change in HbA1c
次要结局
- Change in body weight
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
- Weekly insulin dose (total)
- Change in DTSQs total treatment satisfaction
- Change in HbA1c
- Change in mean 7-point SMPG profiles
- Change in mean post-prandial glucose increment (over all meals)
- Time spent < 3.0 mmol/L (54 mg/dL)
- Time spent > 10.0 mmol/L (180 mg/dL)
- Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL)
- Change in FPG
- Change in Treatment Related Impact Measure - Diabetes (TRIM-D) score
- Change in EQ-5D-5L score
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL], confirmed by BG meter)
- Number of severe hypoglycaemic episodes (level 3)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (8)
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