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临床试验/EUCTR2015-000410-22-DK
EUCTR2015-000410-22-DK进行中(未招募)1 期

Influence of liraglutide on diastolic cardiac function and myocardial perfusion as determined by magnetic resonance imaging in patients with type 2 diabetes: a double-blind randomized parallel-group trial

The Cardiovascular MR Group, Dept. 2011, Rigshospitalet0 个研究点目标入组 40 人开始时间: 2015年6月30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
40

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

  • Male or female patient fully capable of informed consent
  • Informed consent
  • Age 18-80 years (both years inclusive)
  • T2DM diagnosed at least 3 months
  • NYHA class I-III
  • E/e* = 9 or e* (lateral) =10 cm/sec, or both
  • LVEF > 50%
  • LVEDV/BSA < 97 ml/m2
  • Stable on heart medication for 6 weeks prior to randomization
  • Stable on antidiabetic treatment for 30 days prior to randomization
  • T2DM must be either treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
  • 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 36
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 4

排除标准

  • Lack of consent.
  • NYHA class IV
  • Type 1 diabetes mellitus
  • Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomization
  • Glitazon therapy within 30 days prior to randomization
  • Hypertension with inadequate blood pressure control: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure >85 mmHg
  • Supine systolic blood pressure <85 mmHg
  • Significant valvular heart disease
  • Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
  • Myocardial infarction, unstable angina, angina on exertion (=CCS class 2) or coronary revascularization within 3 months prior to randomization
  • Hospitalisation due to incompensated heart disease within 30 days to randomization
  • HbA1c >10%
  • eGFR< 60 ml/min/1,73 m2
  • Liver disease with aspartate aminotransferase/alanine aminotransferase >3 times upper limit of normal
  • Hypokalaemia (P-potassium <3.5 mmol/L) or hyperkalaemia (P-potassium >5.5 mmol/L)
  • Anaemia (haemoglobin <6.5 mmol/L)
  • Conditions that may be associated with changes in markers of fibroses or collagen turnover (eg. on-going or active rheumatological disease requiring anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
  • Prolonged use (> 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to the beginning of the trail
  • Women of childbearing potential who are not on acceptable contraception
  • Pregnant or breastfeeding women
  • Cancer (except basal cell skin cancer or squamous cell skin cancer) unless complete remission for = 5 years
  • Alcohol/drug abuse
  • Chronic or previous acute pancreatitis
  • History of thyroid adenoma or carcinoma
  • Inflammatory bowel disease
  • Clinical signs of diabetic gastroparesis
  • ICD/pacemaker or other contraindications to MRI scan
  • Severe claustrophobia
  • Atrial fibrillation
  • Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia at rest, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
  • Known or suspected hypersensitivity to trial product or related products
  • Current participation in any other clinical intervention trial
  • Receipt of an investigational drug with 30 days prior to the beginning of the trail
  • Other concominant disease or treatment that according to investigator’s assessment makes the patient unsuitable for participation in the study

研究者

发起方
The Cardiovascular MR Group, Dept. 2011, Rigshospitalet

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