EUCTR2011-000300-18-NL进行中（未招募）1 期
REducing with MetfOrmin Vascular Adverse Lesions in T1DM - REMOVA
Maastricht University Medical Centre0 个研究点目标入组 493 人开始时间: 2012年1月5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
- 493
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
- •Type 1 diabetes for five years or more*; age = 40 years; 7.0 = HbA1c < 10.0% (53-86 mmol/mol)
- •AND three or more of the following ten CVD risk factors:
- •(i) BMI = 27 kg/m2
- •(ii) current HbA1c > 8.0% (64 mmol/mol)
- •(iii) known CVD/ peripheral vascular disease
- •(iv) current smoker
- •(v) eGFR < 90 ml/ min/ 1.73 m2
- •(vi) micro- (or macro-) albuminuria [according to local assays and reference ranges]
- •(vii) hypertension (BP¬=140/ 90 mmHg; or established on antihypertensive treatment)
- •(viii) dyslipidaemia [total cholesterol=5.0 mmol/L (200 mg/dL); or HDL cholesterol<1.20 mmol/L (46 mg/dL) [men] HDL cholesterol<1.30 mmol/L (50 mg/dL) [women]; or fasting triglycerides=1.7 mmol/L (150 mg/dL); or established on lipid-lowering treatment
- •(ix) strong family history of CVD (at least one parent, sibling or aunt/uncle with myocardial infarction, CABG or stroke aged < 60 years)
- •(x) duration of diabetes > 20 years.
- •* Type 1 diabetes is defined as diagnosis below age 40 years AND insulin use within 1 year of diagnosis
- •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 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •(i) Women of childbearing age (i.e. continuing menstrual cycle) not using effective contraception
- •(ii) Pregnancy and/or lactation; planning to get pregnant or not using effective contraception
- •(iii) Patients with Acute Coronary Syndrome or Stroke/ Transient Ischaemic Attack within the last three months
- •(iv) Symptomatic angina on mild or moderate exertion
- •(v) Stage 3 or 4 heart failure defined according to the NYHA criteria
- •(vi) Estimated glomerular filtration rate < 45 ml/min/1.73m2 (MDRD)
- •(vii) Contraindications to metformin
- •- hepatic impairment (ALT > 3.0 times ULN)
- •- known hypersensitivity to metformin
- •- acute illness [dehydration, severe infection, shock, acute cardiac failure]
- •- suspected tissue hypoxia
- •(viii) Metformin treatment for more than three months within last two years
- •(ix) Anaemia (haemoglobin < 10.0 g/dL)
- •(x) Ongoing treatment with oral steroids, pramlintide or GLP-1 agonist therapy
- •(xi) Hypoglycaemia unawareness confirmed as significant by site Principal Investigator
- •(xii) Impaired cognitive function/ unable to give informed consent
- •(xiii) Previous carotid surgery or inability to capture adequate carotid images
- •(xiv) Gastroparesis (on gastric emptying studies) confirmed as significant by site Principal Investigator OR more than two hospital admissions with unexplained vomiting in last year
- •(xv) history of biochemically-confirmed acidosis (lactate > 5.0 mmol/L)
- •(xvi) Any coexistent life-threatening condition including diagnosis of cancer within prior two years
- •(xvii) history of alcohol problem or drug abuse
- •(xviii) diabetes other than type 1 diabetes (e.g. secondary to pancreatitis, pancreatectomy or primary pancreatic disease)
- •(xix) Involvement in a clinical trial involving an investigational medicinal product within the last six months
研究者
相似试验
进行中（未招募）
1 期
The REMOVAL study: metformin in type 1 diabetesPeople with type 1 diabetes with risk factors for cardiovascular diseaseMedDRA version: 14.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861EUCTR2011-000300-18-GBHS Greater Glasgow and Clyde493
已完成
3 期
REducing with MetfOrmin Vascular Adverse Lesions in Type 1 diabetes mellitusjuvenile diabetes10018424Type 1 diabetes mellitusNL-OMON43685Medisch Universitair Ziekenhuis Maastricht60
进行中（未招募）
1 期
REduction of risk for cardiovascular events by treatment with metformin in patients with type 1 diabetesMedDRA version: 16.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 1 diabetesEUCTR2011-000300-18-DKHS Greater Glasgow and Clyde Board120
进行中（未招募）
1 期
Pemafibrate to reduce risk of cardiovascular events in patients with diabetes.Reduction of cardiovascular events in patients with Type II DiabetesMedDRA version: 20.0Level: HLTClassification code 10012654Term: Diabetic complications cardiovascularSystem Organ Class: 100000004860EUCTR2016-003818-26-DEKowa Research Institute, Inc.10,000
进行中（未招募）
1 期
Pemafibrate to reduce risk of cardiovascular events in patients with diabetes.EUCTR2016-003818-26-SKKowa Research Institute, Inc.10,000