Effect and Safety of Two Different Dose-escalation Regimens for Once-weekly Semaglutide s.c. in Subjects With Type 2 Diabetes Mellitus Previously Treated With GLP-1 RAs
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in glycosylated haemoglobin (HbA1c)
研究概览
简要总结
This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.
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, age 18 years or older at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
- •The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator.
- •HbA1c of 6.5-10% (48-86 mmol/mol) (both inclusive).
- •Treatment with any therapeutic dose of GLP-1 RA other than once-weekly semaglutide s.c., as defined in the local label, with or without OADs (metformin, DPP-4 inhibitor, SU, glinide, thiazolidinedione, SGLT-2 inhibitor or alpha-glucosidase inhibitor). All doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator's discretion.
排除标准
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 according to Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification.
- •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
Semaglutide 0.50 mg
Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg.
干预措施: Semaglutide (Drug)
Semaglutide 0.25 mg
Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in glycosylated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to week 12
Percent-point
次要结局
- Change in body weight(From baseline (week 0) to week 12)
- Number of treatment emergent gastrointestinal adverse events(From baseline (week 0) to week 12)
- Change in pulse rate(From baseline (week 0) to week 12)
- Change in fasting plasma glucose(From baseline (week 0) to week 12)
- Number of treatment emergent adverse events (TEAEs)(From week 12 to week 17)
- Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes(From baseline (week 0) to week 12)