2023-506084-34-00已完成3 期
A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 23
- 主要终点
- Change in HbA1c from baseline week 0 (V6) to week 26 (V32)
研究概览
简要总结
To demonstrate the effect on glycaemic control of once-weekly insulin icodec, switched unit-to-unit from a daily basal insulin, with or without non-insulin anti-diabetic drugs, in participants with T2D treated with basal insulin. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine U100 after 26 weeks of treatment to a non-inferiority margin of 0.3%-point.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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 or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 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: metformin, 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 RAs, Injectable GLP-1/GIP RA combination products
- •Body mass index (BMI) ≤ 40.0 kg/m2.
排除标准
- •Any episodes 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
Change in HbA1c from baseline week 0 (V6) to week 26 (V32)
Change in HbA1c from baseline week 0 (V6) to week 26 (V32)
次要结局
- Change in time in range 3.9–10.0 mmol/L (70–180 mg/dL)
- Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction
- Number of severe hypoglycaemic episodes (level 3) (safety)
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) (safety)
- 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)
- Time spent < 3.0 mmol/L (54 mg/dL)
- Change in time spent > 10.0 mmol/L (180 mg/dL)
- Mean weekly insulin dose
- Change in body weight
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (23)
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