Efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes - PIONEER 3

ovo Nordisk A/S0 个研究点目标入组 1,863 人开始时间: 2016年1月5日最近更新: 2019年2月28日

适应症

试验速览

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•1. 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.
•2. Diagnosed with T2DM = 90 days prior to day of screening.
•3. HbA1c 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
•4. Stable daily dose of metformin (= 1500 mg or maximum tolerated dose as documented in 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 subject medical record) within 90 days prior to the day of screening.
•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 1395
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 465

•1. 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).
•For certain specific countries: Additional specific requirements apply.
•2. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
•3. History of pancreatitis (acute or chronic).
•4. 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).
•5. 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.
•6. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
•7. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
•8. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
•9. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas).

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