NCT03811561进行中（未招募）3 期
Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 446
- 主要终点
- Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
研究概览
简要总结
This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 greater than or equal to 18 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus.
- •HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
- •Eye inclusion criteria (both eyes must meet all criteria):
- •Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
- •No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
- •No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
- •Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
- •No previous treatment with pan-retinal laser photocoagulation
- •No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial
- •No substantial media opacities that would preclude successful imaging
排除标准
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Subjects presently classified as being in New York Heart Association (NYHA) Class IV
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m^2
- •Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
- •Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation.
- •Receipt of any investigational medicinal product within 30 days before screening
- •Previous participation in this trial. Participation is defined as randomisation
- •Known or suspected hypersensitivity to trial products or related products
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
研究组 & 干预措施
Semaglutide
Experimental
Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
干预措施: Semaglutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
干预措施: Placebo (semaglutide) (Drug)
结局指标
主要结局
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
时间窗: Year 5
Percentage of subjects (yes/no).
次要结局
- Change in body weight.(Week 0, Year 5)
- Change in glycosylated haemoglobin (HbA1c).(Week 0, Year 5)
- Change in systolic and diastolic blood pressure.(Week 0, Year 5)
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.(Week 0-Year 5)
- Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.(Year 5)
- Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.(Year 5)
- Presence of at least 3 steps ETDRS subject level improvement.(Year 5)
- Presence of at least 2 steps ETDRS subject level improvement.(Year 5)
- Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye.(Up to 5 years)
- Change in visual acuity in the worse seeing eye.(Week 0, Year 5)
- Change in visual acuity in the better seeing eye.(Week 0, Year 5)
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.(Week 0-Year 5)
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.(Week 0-Year 5)
- Presence of at least 2 steps ETDRS subject level progression.(Year 5)
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.(Week 0-Year 5)
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF).(Week 0-Year 5)
- Presence of persistent visual acuity up to 38 ETDRS letters in either eye.(Year 5)
- Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.(Year 5)
- Presence of ciDME in either eye.(Year 5)
- Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.(Year 5)
- Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.(Week 0, Year 5)
研究者
研究点 (446)
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