Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 582
- 试验地点
- 128
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) at Week 26
研究概览
简要总结
This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.
Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin.
The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.
The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken.
At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year).
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
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
- •Male or female aged greater than or equal to 18 years at the time of signing informed consent.
- •Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
- •Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.
- •HbA1c below10% at screening visit based on analysis from central laboratory.
排除标准
- •Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- •Chronic heart failure classified as New York Heart Association (NYHA) 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 + insulin aspart
insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.
干预措施: insulin icodec (Drug)
Insulin icodec + insulin aspart
insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.
干预措施: insulin aspart (Drug)
Insulin degludec + insulin aspart
insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.
干预措施: insulin degludec (Drug)
Insulin degludec + insulin aspart
insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.
干预措施: insulin aspart (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) at Week 26
时间窗: Baseline (week 0), week 26
Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.
次要结局
- Change in Glycosylated Haemoglobin (HbA1c) at Week 52(Baseline (week 0), week 52)
- Change in Fasting Plasma Glucose (FPG)(Baseline (week 0), week 26)
- Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System(From week 22 to week 26)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction(Baseline (week 0), week 26)
- Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26(From baseline (week 0) to week 26)
- Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57(From baseline (week 0) to week 57)
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose [BG] Meter): From Baseline (Week 0) to Week 26(From baseline (week 0) to week 26)
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by BG Meter): From Baseline (Week 0) to Week 57(From baseline (week 0) to week 57)
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26(From baseline (week 0) to week 26)
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57(From baseline (week 0) to week 57)
- Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26(From baseline (week 0) to week 26)
- Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57(From baseline (week 0) to week 57)
- Percentage of Time Spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System(From week 22 to week 26)
- Percentage of Time Spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System(From week 22 to week 26)
- Mean Total Weekly Insulin Dose: From Week 24 to Week 26(From week 24 to week 26)
- Mean Total Weekly Insulin Dose: From Week 50 to Week 52(From week 50 to week 52)
- Change in Body Weight(Baseline (week 0), week 26)