EUCTR2010-022695-31-SE进行中（未招募）不适用
Effects on subclinical heartfailure in type 2 diabetic subjects on liraglutide treatment versus glimepiride both in combination with metformin. - Liraglutide and heartfailure
Karolinska Institute, Södersjukhuset AB0 个研究点开始时间: 2011年2月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1Type 2 diabetes.
- •2Heart Failure, visualized with echocardiography, one of the following (2.1, 2.2 or 2.3).
- •2.1Ejection Fraction = 50%.
- •2.2Decreased systolic velocity (four chamber view) where two, out of four segments (Septum, Lateral, Inferior and Anterior Wall) has a relative decrease in velocity of 20% compared to a normal population.
- •2.3Evidence of diastolic dysfunction as shown by abnormal left ventricular relaxation, filling, diastolic distensibility or stiffness. An E/E’ ratio (ratio of early diastolic velocities of mitral inflow derived Doppler imaging and myocardial movement derived by tissue Doppler imaging) >15 is considered diagnostic of diastolic dysfunction and an E/E' ratio < 8 as diagnostic of the absence of diastolic heart failure. An increased left atrial size (>49 ml/ m2) and an increased left ventricular mass (>122 g/m2 in women and >149 g/m2 in men) are considered sufficient evidence of diastolic dysfunction when the E/E' ratio is inconclusive.
- •3HbA1c (accordingly to IFCC) 60 mmol/mol – 95 mmol/mol.
- •4If antihypertensive treatment, the medication has to be stable, no change, for the last 1 month.
- •5Male and female subjects, 18-70 years of age.
- •6Signed informed consent form.
- •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
- •1.Type 1 diabetes (autoantibody positive).
- •2.Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors (DPP-IV inhibitor) or glimeperid.
- •3.Previous treatment with glitazones within 6 months.
- •4.Previous treatment with other sulphonylurea within 3 months.
- •5.Previous treatment with insulin (any regimen) within 1 month..
- •6.Known severe heart failure, classified as NYHA 3-4.
- •7.Significant ischemic heart disease (defined as angina-limited exercise or unstable angina); documented acute myocardial infarction (MI) within the previous 8 weeks.
- •8.Active myocarditis; malfunctioning artificial heart valve.
- •9.Atria fibrillation or flutter
- •10.History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block.
- •11.Implanted pacemaker.
- •12.Supine systolic blood pressure <85 mm Hg or >200 mm Hg?
- •13.Primary renal impairment (creatinine clearance < 30 ml/min), or creatinine clearance < 60 ml/min if treated with metformin.
- •14.Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/l or >5.5 mmol/l).
- •15.Significant anemia (Hb < 90 g/l)
- •16.Treatment with another investigational agent within 30 days before study entry, judged by the investigator.
- •17.Severe gastrointestinal disease, including gastroparesis. As judged by the investigator.
- •18.Body mass index (BMI) > 40 kg/m2.
- •19.Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Patients with intraepithelial squamous cell carcinoma of the skin treated with topical 5FU and subjects with basal cell skin cancer are allowed to enter the trial.
- •20.Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice).
- •21.Current drug and alcohol abuse.
- •22.History of acute or chronic pancreatitis
- •23.Subjects considered by the investigator to be unsuitable for the study.
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