CTRI/2018/02/011670Other3 期
Efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •2. Male or female, age >= 18 years at the time of signing informed consent.
- •For Japan only: Male or female, age >= 20 years at the time of signing informed consent.
- •3. Diagnosed with type 2 diabetes mellitus >= 90 days prior to day of screening.
- •4. HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive).
- •5. Stable daily dose of metformin (>= 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with SU (>= half of the maximum approved dose according to local label or maximum tolerated dose as documented in the subject medical record) within 90 days prior to the day of screening.
排除标准
- •1. Known or suspected hypersensitivity to trial product(s) or related products.
- •2. Previous participation in this trial. Participation is defined as signed informed consent.
- •3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
- •potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- •4.Receipt of any investigational medicinal product within 90 days before screening. 5. Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol.
- •6. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
- •7. History of pancreatitis (acute or chronic).
- •8. 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).
- •9. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening.
- •10. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- •11. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
- •13. 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.
- •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 in-situ carcinomas).
研究者
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