EUCTR2015-005326-19-PL进行中（未招募）1 期
Efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment. A 26-week randomised, double-blind, placebo-controlled trial - PIONEER 5 – renal impairment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •2. Male or female, age above or equal to 18 years at the time of signing informed consent.
- •3. Diagnosed with type 2 diabetes mellitus = 90 days prior to day of screening.
- •4. HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
- •5. Moderate renal impairment defined as estimated glomerular filtration rate of 30-59 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula.
- •6. Stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens:
- •– 1-2 of the following oral anti-diabetic drugs: - Metformin = 1500 mg or maximum tolerated dose documented in the subject medical record), - Sulfonylurea (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
- •– Basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin)
- •– Metformin (= 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 259
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For certain specific countries: Additional specific requirements apply.
- •2. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
- •3. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
- •4. History of pancreatitis (acute or chronic).
- •5. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- •6. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation.
- •7. Subjects presently classified as being in New York Heart Association Class IV.
- •8. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •9. Subjects with alanine aminotransferase > 2.5 x upper normal limit.
- •10. Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (> 2200 mg/24 hours or > 2200 mg/g).
- •11. Use of systemic immunosuppressive treatment within 90 days prior to screening.
- •12. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of = 14 days.
- •13. Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.
- •14. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
- •15. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
研究者
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