EUCTR2015-002837-23-GB进行中（未招募）1 期
ow-dose Glibenclamide in Type 2 Diabetes Mellitus - Part A (LEGEND-A) - Low dosE GlibENclamide in Diabetes - Part A (LEGEND-A)
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
- 16
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
入选标准
- •1. Diagnosis of T2DM.
- •2. Age 18 years or over.
- •3. Diet controlled or on metformin only for diabetic control.
- •4. Body mass index 40 kg/m2 or less.
- •5. HbA1c 7.0% to 9.5% (53mmol/mol to 80mmol/mol) inclusive.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Taking anti-diabetic therapies other than metformin
- •2.Pregnancy or women of childbearing age without adequate contraception
- •3.Women who are breastfeeding
- •4.Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse
- •5.Known sight-threatening retinopathy
- •6.Renal impairment (eGFR < 60 ml/min; CKD Stage 3)
- •7.Abnormal liver function tests (> 1.5 x upper limit of normal range)
- •8.Known ischaemic heart disease or heart failure
- •9.Known history of a stroke
- •10.Known history of porphyria
- •11.Concomitant use of miconazole or other oral antifungal medication.
- •12.Known or suspected allergy to trial product or related products
- •13.Oral steroid treatment 30 days prior to randomisation or at any time during the trial period.
- •14.Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient’s ability to participate in the protocol.
- •15.Ketoacidosis
- •16.Felt to be unsuitable to participate in the trial in the opinion of the Chief Investigator.
- •17.Receipt of any investigational trial drug within 3 month prior to participation in the current trial.
研究者
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