Status:
COMPLETED
The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus
Lead Sponsor:
Flyvbjerg, Allan, DMSc
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Hyperglycemia
Chronic Heart Failure
Eligibility:
All Genders
30-85 years
Phase:
NA
Brief Summary
Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic control in patients with the combination of T2D and CHF is complicated and the currently available treatments have...
Detailed Description
Background The number of patients with diabetes in Denmark has doubled in the preceding 10-years period and has now increased to 271.000 individuals (5% of the population). T2D is a major risk factor ...
Eligibility Criteria
Inclusion
- Able to understand the written patient information and to give informed consent
- CHF, NYHA-class I, II or III at visit 0
- LVEF ≤45 %
- Age 30 to 85 (both inclusive)
- Stable pharmacological treatment of heart failure according to ESC guidelines for the last 3 months prior to randomisation (visit 1)
- For patients with diabetes exclusively:
- T2D (WHO criteria), diagnosed at least 3 months prior to visit 0
- Patients with diabetes must be either untreated or 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
- Stable and optimal dose of anti diabetic treatment for 30 days prior to randomisation (visit 1)
Exclusion
- Myocardial infarction (MI), unstable angina or coronary revascularization within the last three months prior to visit 1
- Hospitalisation due to incompensated heart disease within 30 days prior to randomisation (visit 1)
- CHF (NYHA class IV)
- ECG suggestive of malign ventricular arrhythmia at visit 0
- Type 1 diabetes
- HbA1c \> 10% measured at visit 0
- Use of GLP-1 receptor agonists (Exenatide, Liraglutide or other) or glitazones, pramlintide or any DPP-IV inhibitor within 30 days prior to randomisation (visit 1)
- Known or suspected hypersensitivity to trial product or related products
- Alcohol/drug abuse
- Pregnant or nursing women
- Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- Cancer unless in complete remission for ≥5 years
- Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- Inflammatory bowel disease
- Acute or chronic pancreatitis
- Gastroparesis
- Compromised kidney function (eGFR \< 30 ml/min), dialysis or kidney transplantation
- History of thyroidea adenoma or carcinoma
- Severely elevated blood pressure (systolic \>180 mmHg and/or diastolic \>105 mmHg)
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Simultaneous participation in any other clinical intervention trial
- Receipt of an investigational drug with 30 days prior to visit 0
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01472640
Start Date
November 1 2011
End Date
October 1 2015
Last Update
October 12 2015
Active Locations (4)
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1
Skejby University Hospital
Aarhus, Denmark, 8200
2
Steno Diabetes Center
Gentofte Municipality, Denmark, 2820
3
Herlev University Hospital
Herlev, Denmark, 2730
4
Odense University Hospital
Odense, Denmark, 5000