CTRI/2017/06/008830进行中（未招募）3 期
Efficacy and Safety of Oral Semaglutide versus Placeboin Subjects with Type 2 Diabetes Mellitus treated with insulin
ovo Nordisk India Private Ltd0 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
- 进行中（未招募）
- 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
- •1Informed 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.
- •2Male or female, age above or equal to 18 years at the time of signing informed consent.
- •3Diagnosed with type 2 diabetes mellitus >= 90 days prior to the day of screening.
- •4HbA1c of 7.0-9.5 percentage(53-80 mmol/mol) (both inclusive).
- •5Stable 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:
- •1Basal insulin alone
- •2Basal and bolus insulin in any combination
- •3Premixed insulin including combinations of soluble insulins
- •4Concomitant 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.
排除标准
- •1Known or suspected hypersensitivity to trial product(s) or related products.
- •2Previous participation in this trial. Participation is defined as signed informed consent.
- •3Female 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).
- •4Receipt of any investigational medicinal product within 90 days before screening.
- •5Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol.
- •6Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
- •7History of pancreatitis (acute or chronic).
- •8History 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).
- •9Any 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.
- •10Classified as being in New York Heart Association (NYHA) Class IV.
- •11Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •12Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
- •13Treatment 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.
- •14Known hypoglycaemic unawareness according to Clarkeâ??s questionnaire.
- •15Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
- •16History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
- •17Subjects with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).
研究者
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