EUCTR2013-000418-39-PL进行中（未招募）1 期
Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe - e-PREDICE
EVIDEM CONSULTORES SL (EVIDEM)0 个研究点目标入组 2,000 人开始时间: 2014年10月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
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 1500
- •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 of previous myocardial infarction in baseline EKG.
- •Current renal replacement therapy.
- •A previous diagnosis of liver cirrhosis or chronic hepatitis*, or an elevation of liver enzymes (AST and or ALT) >3 tiems normal ranges.
- •Previous diagnosis of Chronic heart failure (NYHA class III or higher).
- •A prior solid organ transplant or awaiting solid 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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