A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 877
- 试验地点
- 181
- 主要终点
- Change in glycosylated haemoglobin (HbA1c)
研究概览
简要总结
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 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 type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
- •Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
- •HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
- •Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.
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 childbearing potential and not using adequate contraceptive method.
- •Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- •Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
- •Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
- •Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
研究组 & 干预措施
Insulin icodec + insulin aspart
Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
干预措施: Insulin icodec (Drug)
Insulin icodec + insulin aspart
Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
干预措施: Insulin aspart (Drug)
Insulin glargine+ insulin aspart
Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
干预措施: Insulin glargine (Drug)
Insulin glargine+ insulin aspart
Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Change in glycosylated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to week 26
Measured in percentage (%)-points.
Change in glycosylated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to week 26
Measured in percentage (%)-points.
次要结局
- Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])(From baseline (week 0) to week 31)
- Mean total weekly insulin dose(From week 24 to week 26)
- Change in body weight(From baseline (week 0) to week 26)
- Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))(From baseline (week-2-0) to week 22-26)
- Time spent less than (<)3.0 mmol/L (54 mg/dL)(From week 22 to week 26)
- Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)(From baseline (week-2-0) to week 22-26)
- Number of severe hypoglycaemic episodes (level 3)(From baseline (week 0) to week 31)
- Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)(From baseline (week 0) to week 31)
- Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3)(From baseline (week 0) to week 31)