A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
研究概览
简要总结
This study is testing the effect of a new study medicine NNC0194-0499 in type 1 diabetes. The purpose of the study is to compare the effect of NNC0194-0499 on the blood sugar levels of participants with type 1 diabetes when taken in combination with semaglutide or placebo. All participants will receive standard of care insulin treatment. The study will last for about 36 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body mass index 22-35 kilogram per square meter (kg/m^2) (both inclusive) for Part A and 27-35(kg/m^2) (both inclusive) for Part B at the day of screening.
- •Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening.
- •Treated with multiple daily insulin injections and stable insulin dose greater than (>) 90 days prior to the day of screening, as judged by the investigator.
- •Use of Continuous glucose monitoring (CGM) device > 180 consecutive days prior to the day of screening.
- •Glycated haemoglobin (HbA1c) from 7.2 - 9.0% (both inclusive).
- •Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- •Ability and willingness to wear the Novo Nordisk provided CGM device according to the protocol including replacement of CGM sensor at home.
- •Ability and willingness to refrain from wearing own CGM/Flash glucose monitor for the duration of the study, as judged by the investigator.
排除标准
- •Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Treatment with glucagon-like peptide-1(GLP-1) RA within 90 days before screening.
- •Use of any medication with unknown or unspecified content within 90 days before screening.
- •Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days prior to the day of screening.
- •Any episode of diabetic ketoacidosis within 90 days before screening.
研究组 & 干预措施
Part A: NNC0194-0499/Placebo
After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo.
干预措施: Placebo (Drug)
Part B: NNC0194-0499/Placebo + Semaglutide
After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.
干预措施: Placebo (Drug)
Part B: NNC0194-0499/Placebo + Semaglutide
After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.
干预措施: NNC0194-0499 (Drug)
Part B: NNC0194-0499/Placebo + Semaglutide
After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.
干预措施: Semaglutide (Drug)
Part A: NNC0194-0499/Placebo
After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo.
干预措施: NNC0194-0499 (Drug)
结局指标
主要结局
Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
时间窗: From baseline (day -14 - -1) to day 36-49 / day 106-119
Percentage point (%-points).
Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
时间窗: From baseline (day -14 - -1) to day 92-105 / day 162-175
%-points.
次要结局
- Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)(Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175)
- Time below range (TBR) <3.9 mmol/L (70 mg/dL)(Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175)
- Change in mean total daily insulin dose per kg(Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175)
- Change in coefficient of variation (CV) of sensor glucose, total(Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175)
- Change in mean sensor glucose (SG)(Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175)
- Time below range (TBR)<3.0 mmol/L (54 mg/dL)(Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175)
- Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL)(Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175)
- Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL)(Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175)
- Number of severe hypoglycaemic episodes (level 3)(Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211)
- Change in triglycerides(Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176)
- Number of adverse events (AEs)(Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211)