EUCTR2013-000418-39-ES进行中（未招募）不适用
Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe - e-PREDICE
FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES (FIRCAVA)0 个研究点目标入组 3,000 人开始时间: 2014年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
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
- •- Men and women
- •- Age 45 -74 years
- •- Impaired Fasting Glucose (IFG): FPG 6.1 to 6.9mmol/l and 2-h PG <7.8mmol/L; or Impaired Glucose Tolerance (IGT): FPG <7.0mmol/L and 2h PG >_7.8 and <11.1 mmol/L; or both conditions;
- •- Informed consent given
- •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 2500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •- Type 1 diabetes.
- •- Known* or unknown T2D (including screen detected T2D) with or without pharmacological treatment.
- •- Use of a GLP-1 receptor agonist (exenatide or other) or pramlintide or any dipeptidyl peptidase-4 (DPP-4) inhibitor or metformin within the 3 months prior to enrolment.
- •- Use of insulin or long-acting insulin analogue within 3 months prior to enrolment
- •- Any previous cardiovascular or cerebrovascular clinically documented event or revascularization procedure
- •- Clinical Evidence of macro-vascular complications (overt clinical cardiovascular disease) at enrolment, including angina (stable or unstable) and evidence or previous myocardial infarction in baselina EKG.
- •- Current renal replacement therapy
- •- Previous diagnosis of liver cirrhosis or chronic hepatitis*, or an elevation of liver enzymes (AST and or AST) >3 times normal ranges
- •- Previous diagnosis of Chronic Heart Failure (NYHA class III or higher)
- •- A prior solid organ transplant or waiting for organ transplant
- •- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen?s disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial
- •- Any acute condition or exacerbation of chronic condition that would in the Investigator's opinion interfere with the initial trial visit schedule and procedures
- •- Known or suspected hypersensitivity to trial products or related products
- •- Known use of non prescribed narcotics or illicit drugs.
- •- Simultaneous participation in any other clinical trial of an investigational agent.
- •- Females of childbearing potential who are pregnant (all fertile women will be tested for before randomization), breast-feeding or intend to become pregnant.
- •- Presence of cataract that impedes the retinal evaluation of both eyes
- •- Other previously diagnosed retinal diseases
- •- Any diseases that would prevent the measurement of primary endpoints
- •- Dementia, mental disorder or evident cognitive impairment unable to give informed consent
- •- End-stage or metastatic cancer
- •- Institutionalization
- •- Renal function impairment: GFR <60 ml/min/1.73m2
- •- Contraindication to any of the study drugs (metformin or linagliptin). This includes: ALT > 3 times the upper limit of normal, history of cirrhosis or hepatitis, suspected renal artery stenosis, recent gastrointestinal bleeding (within the last year), pregnant, breastfeeding or a female of child-bearing potential not on reliable contraception and also any circumstance where ongoing medication might lead to potential adverse drug interaction with components of the trial medications.
- •- Any other reason, medical condition, ongoing medication or significant disability that would prevent the participant complying with trial consent, treatment and follow-up procedures or potentially jeopardise her/his medical care.
- •* Previous diagnosis should be documented after medical record review
研究者
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