EUCTR2009-013157-15-ES进行中（未招募）1 期
A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial. - CAROLINA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,000
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
- •Documented diagnosis of T2DM and concurrently 1) insufficient glycaemic control and 2) a high risk of CV events prior to informed consent
- •1)Insufficient glycaemic control (at Visit 1a) defined as:
- •a) HbA1c 6.5 - 8.5% (48 - 69 mmol/mol) while patient is treatment naïve or treated with:
- •- metformin monotherapy, or
- •- alpha-glucosidase inhibitor monotherapy (e.g. acarbose, voglibose), or
- •- metformin + alpha-glucosidase inhibitor (e.g. acarbose, voglibose), or
- •b) HbA1c 6.5 - 7.5% (48 - 58 mmol/mol) while patient is treated with
- •- sulphonylurea (SU) monotherapy, or
- •- glinide monotherapy (e.g. repaglinide, nateglinide), or
- •- metformin + sulphonylurea (combination maximal up to 5 years), or
- •- metformin + glinide (combination maximal up to 5 years)
- •2)High risk of CV events defined as any one (or more) of A), B), C) or D):
- •A) Previous Vascular Disease:
- •- Myocardial infarction (> 6 weeks prior to informed consent)
- •- Documented coronary artery disease (?50% luminal diameter narrowing of left main coronary artery or in at least two major coronary arteries in angiogram)
- •-Percutaneous Coronary Intervention (PCI) > 6 weeks prior informed consent
- •-Coronary Artery By-pass Grafting (CABG) > 4 years prior to informed consent or with recurrent angina following surgery
- •-Ischemic or hemorrhagic stroke (> 3 months prior to informed consent)
- •-Peripheral occlusive arterial disease (previous limb bypass surgery or percutaneous transluminal angioplasty; previous limb or foot amputation due to circulatory insufficiency, angiographic or ultrasound detected significant vessel stenosis (>50%) of major limb arteries (common iliac artery, internal iliac artery, external iliac artery, femoral artery, popliteal artery), history of intermittent claudication, with an ankle: arm blood pressure ratio < 0.90 on at least one side).
- •B) Evidence of vascular related end-organ damage:
- •- Moderately impaired renal function (as defined by modified diet of renal disease (MDRD) formula) with estimated glomerular filtration rate [eGFRF]) 30-59 mL/min/1.73 m2
- •- Random spot urinary albumin:creatinine ratio ? 30 ?g/mg in two of three unrelated specimens in previous 12 months prior Visit 1a
- •-Proliferative retinopathy defined as retinal neovascularisation or previous retinal laser coagulation therapy.
- •C) Age ? 70 years (at Visit 1a)
- •D) At least two of the following CV risk factors:
- •-Type 2 diabetes mellitus duration > 10 years at Visit 1a.
- •-Systolic blood pressure (SBP) > 140 mmHg (or on at least one blood pressure lowering treatment at Visit 1a)
- •-Current daily cigarette smoking
- •-LDL cholesterol ? 135 mg/dL (3.5 mmol/l) (or specific current treatment for this lipid abnormality) at Visit 1a
- •3)Body Mass Index (BMI) ? 45 kg/m2 at Visit 1a
- •4)Age ? 40 and ? 85 years at Visit 1a
- •5)Signed and dated written informed consent at the latest by the date of Visit 1a, in accordance with GCP and local legislation
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Type 1 diabetes mellitus
- •?Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, GLP-1 analogue/agonists, DPP-IV inhibitors or any insulin) prior to informed consent. Note: previous short term use of insulin (up to two weeks) is allowed (e.g. during hospitalisation) if taken at least 8 weeks prior informed consent.
- •?Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) within 3 months prior to informed consent
- •?Any previous (or planned within next 12 months) bariatric surgery (open or laparascopic) or intervention (gastric sleeve)
- •?Current treatment with systemic steroids at time of informed consent or pre-planned initiation of such therapy
- •?Change in dose of thyroid hormones within 6 weeks prior informed consent
- •?Active liver disease or impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN)
- •?Pre-planned coronary artery re-vascularization (PCI, CABG) within next 6 months
- •?Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
- •?Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than 5 years for non-CV causes, or has cancer other than non-melanoma skin cancer within last 3 years, or has any other condition than mentioned which in the opinion of the investigator, would not allow safe participation in the study
研究者
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