EUCTR2016-000988-16-GR进行中（未招募）1 期
Efficacy and Safety of Oral Semaglutide versus Placebo in Subjects with Type 2 Diabetes Mellitus treated with insulin - A 52-week, randomised, placebo-controlled trial, double-blinded during the initial 26 weeks
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 590
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. For Japan only: Male or female, age above or equal to 20 years at the time of signing informed consent.
- •3. Diagnosed with type 2 diabetes mellitus = 90 days prior to the day of screening.
- •4. HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
- •5. Stable treatment with one of the following insulin regimens (minimum 10 IU/day) = 90 days
- •prior to the day of screening. Maximum 20% change in total daily dose is acceptable:
- •- Basal insulin alone
- •- Basal and bolus insulin in any combination
- •- Premixed insulin including combinations of soluble insulins
- •Concomitant treatment with stable daily dose of metformin (= 1500 mg or maximum tolerated
- •dose as documented in the subject medical record) = 90 days prior to the day of screening is
- •allowed. For Japan only: Concomitant treatment with metformin is only allowed in combination with basal insulin alone (not in combination with basal-bolus or premixed insulin including combinations of soluble insulins).
- •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 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
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 Greece only: adequate contraceptive measures are defined as combined hormonal contraception (containing oestrogen and progesterone), which suppress ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception which suppress ovulation (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy, sexual abstinence. For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives.
- •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 (MEN 2) or Medullary
- •Thyroid Carcinoma (MTC).
- •4. History of pancreatitis (acute or chronic).
- •5. History of major surgical procedures involving the stomach and potentially affecting absorption
- •of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- •6. Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina
- •or transient ischaemic attack within the past 180 days prior to the day of screening and
- •randomisation.
- •7. Classified as being in New York Heart Association (NYHA) Class IV.
- •8. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •9. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
- •10. 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 change of insulin treatment for acute illness for a total of = 14 days.
- •11. Known hypoglycaemic unawareness according to Clarke’s questionnaire.
- •12. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
- •photography or dilated fundoscopy performed within 90 days prior to randomisation.
- •13. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
- •14. Subjects with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).
研究者
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