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
概览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 429
- 试验地点
- 142
- 主要终点
- Change in glycated hemoglobin (HbA1c)
概览
简要总结
This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 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 equal to (≥) 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 greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products.
- •Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2).
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.
研究组 & 干预措施
Insulin icodec
Participants will receive Insulin icodec subcutaneously once weekly.
干预措施: Insulin icodec (Drug)
Insulin icodec
Participants will receive Insulin icodec subcutaneously once weekly.
干预措施: Insulin glargine (Drug)
Insulin glargine U100
Participants will receive Insulin glargine subcutaneously once daily.
干预措施: Insulin icodec (Drug)
Insulin glargine U100
Participants will receive Insulin glargine subcutaneously once daily.
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Change in glycated hemoglobin (HbA1c)
时间窗: From baseline (week 0) to week 26
Percentage point (%-point).
次要结局
- Number of severe hypoglycaemic episodes (level 3)(From baseline (week 0) to week 31)
- Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter)(From baseline (week 0) to week 31)
- Time spent < 3.0 mmol/L (54 mg/dL)(From week 22 to 26)
- Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL))(From baseline (week -4 to 0) to week 22-26)
- Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction(From baseline (week 0) to week 26)
- Change in time spent > 10.0 mmol/L (180 mg/dL)(From baseline (week-4 to 0) to week 22-26)
- Mean weekly insulin dose(From week 24 to week 26)
- Change in body weight(From baseline (week 0) to week 26)
- 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)(From baseline (week 0) to week 31)