EUCTR2009-013157-15-SE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 (if intolerant or contra-indicated to first line antidiabetic treatment):
- •- metformin monotherapy, or
- •- alpha-glucosidase inhibitor monotherapy (e.g. acarbose, voglibose), or
- •- metformin + alpha-glucosidase inhibitor 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), or
- •- alpha-glucosidase inhibitor + SU (combination maximal up to 5 years)
- •- alpha-glucosidase inhibitor + 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 µg/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 4000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •Type 1 diabetes mellitus
- •Any history and/or current treatment with other antidiabetic drugs (e.g.
- •rosiglitazone, pioglitazone, GLP-1 analogue/agonists, DPP-IV inhibitors or
- •any insulin) prior to informed consent. Note 1: This also includes clinical
- •trials where these antidiabetic drugs have been provided to the patient. Note
- •2: Previous short term use of insulin (up to two consecutive weeks) is
- •allowed (e.g. during hospitalisation) if taken at least 8 weeks prior informed
- •Treatment with anti-obesity drugs within 3 months prior to informed consent
- •Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3
- •mmol/L) after an overnight fast during placebo run-in and confirmed by
- •a second measurement (not on the same day)
- •Any previous (or planned within next 12 months) bariatric surgery (open or
- •laparascopic) or intervention (gastric sleeve)
- •Current treatment with systemic corticosteroids at time of informed consent
- •or pre-planned initiation of such therapy. Note: inhaled use of steroids (e.g.
- •for asthma/COPD) is no exclusion criterion, as this does not cause
- •systemic steroid action
- •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) as determined at visit 1a
- •Pre-planned coronary artery re-vascularisation (PCI, CABG) within next 6
- •months after V1a or any previous PCI and/or CABG = 6 weeks prior
- •informed consent
- •Known hypersensitivity or allergy to the investigational product or its
- •excipients, or glimepiride (or the SU class)
- •Inappropriateness of glimepiride treatment for renal safety issues or other
- •issues (e.g. allergy) according to local prescribing information
- •Congestive heart failure of NYHA class III or IV
- •Acute or chronic metabolic acidosis (present condition in patient history)
- •Hereditary galactose intolerance
- •Alcohol or drug abuse within the 3 months prior to informed consent
- •that would interfere with trial participation
- •Participation in another trial with an investigational drug given within 2
- •months prior to informed consent
- •Pre-menopausal women (last menstruation = 1 year prior to informed
- •consent) who are nursing or pregnant,or are of child-bearing potential
- •and are not practicing an acceptable method of birth control (acceptable
- •methods of birth control include tubal ligation, transdermal patch, intra
- •uterine devices/systems (IUDs/IUSs), oral, implantable or injectable
- •contraceptives, sexual abstinence (if allowed by local authorities), double
- •barrier method and vasectomised partner) or do not plan to continue
- •using acceptable method of birth control throughout the study and do
- •not agree to submit to periodic pregnancy testing during participation in
- •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
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研究者
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