EUCTR2017-003219-20-HR进行中（未招募）1 期
Effect of semaglutide once-weekly versus insulin aspart three times daily, both as add on tometformin and optimised insulin glargine (U100) in subjects with type 2 diabetesA 52-week, multi-centre, multinational, open-label, active-controlled, two armed, parallel-group,randomised trial in subjects with type 2 diabetes - SUSTAIN 11
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,043
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
- •- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- •- Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening
- •- Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening
- •- Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors
- •- Haemoglobin A1c (HbA1c) of greater than 7.5% to less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)
- •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 1430
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 613
排除标准
- •- History or presence of pancreatitis (acute or chronic)
- •- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- •- Subjects presently classified as being in New York Heart Association Class IV
- •- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed
- •- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to run-in
研究者
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