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临床试验/NL-OMON35173
NL-OMON35173已完成4 期

The effect of exenatide compared to insulin glargine on cardiac function and metabolism in type 2 diabetic patients with congestive heart failure: a randomized-controlled trial - CARDEXINE

Vrije Universiteit Medisch Centrum0 个研究点目标入组 62 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
62

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Patients:
  • Type 2 diabetic patients
  • Male and postmenopausal female
  • Age 18 years and above
  • Metformin therapy (stable, maximum tolerable dose for 2 months)
  • HbA1c 6.5-10%
  • Confirmed congestive heart failure (NYHA, functional class II-IV)
  • Ejection Fraction (EF)<50%
  • Stable standard therapy for their cardiac condition for 3 months prior to entering the study;- Healthy controls:
  • Male and postmenopausal female
  • Age 18 years and above
  • No known acute or chronic disease

排除标准

  • - Patients:
  • Type 1 diabetes
  • Serious renal (creatinine clearance< 50 ml/min) or liver impairment
  • (Receiving treatment for) malignant disease
  • Cardiovascular event< 3 months prior to inclusion
  • Acute congestive heart failure
  • Any reason for not being able to sustain the imaging studies (impairment to understand the aim of the study/procedures, implanted devices, claustrophobia, atrial fibrillation, orthopnoe)
  • Contraindications for the use of exenatide/insulin
  • Use of insulin, thiazolidiones, (other than study) incretin-based therapies within 4 months of screening
  • Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (>2 weeks) within 2 weeks immediately prior to screening;- Healthy controls:
  • Chronic use of any drug
  • Impaired glucose tolerance (as assessed by a 75-g oral glucose tolerance test)

研究者

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