Status:
COMPLETED
Liraglutide and Heart Failure in Type 2 Diabetes
Lead Sponsor:
Thomas Nystrom
Collaborating Sponsors:
Örebro University, Sweden
Conditions:
Congestive Heart Failure
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin with insulinotropic properties. Apart from the glycemic actions, cardiovascular effects by GLP-1 have recently been reviewed. Receptor...
Detailed Description
The subjects will attend a screening visit (Visit 1) in order to assess their eligibility. If found eligible, the subjects will return at Visit 2 within approximately 4 weeks, after Visit 1, with an u...
Eligibility Criteria
Inclusion
- Type 2 diabetes.
- Heart Failure, visualized with echocardiography, one of the following (2.1, 2.2 or 2.3).
- Ejection Fraction ≤ 50%.
- Decreased 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.
- Evidence 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.
- HbA1c (accordingly to IFCC) 47 mmol/mol - 95 mmol/mol.
- If antihypertensive treatment, the medication has to be stable, no change, for the last 1 month.
- Male and female subjects, 18-80 years of age.
- Signed informed consent form.
Exclusion
- Type 1 diabetes (autoantibody positive).
- Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors (DPP-IV inhibitor) or glimeperide.
- Previous treatment with glitazones within 6 months.
- Previous treatment with other sulphonylurea within 3 months.
- Previous treatment with insulin (any regimen) within 1 month.
- Known severe heart failure, classified as NYHA 3-4.
- Significant ischemic heart disease (defined as angina-limited exercise or unstable angina); documented acute myocardial infarction (MI) within the previous 8 weeks.
- Active myocarditis; malfunctioning artificial heart valve.
- Atria fibrillation or flutter
- History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block.
- Implanted pacemaker.
- Supine systolic blood pressure \<85 mm Hg or \>200 mm Hg.
- Primary renal impairment (creatinine clearance \< 30 ml/min), or creatinine clearance \< 60 ml/min if treated with metformin.
- Uncorrected hypokalemia or hyperkalemia (potassium \<3.5 mmol/l or \>5.5 mmol/l).
- Significant anemia (Hb \< 90 g/l)
- Treatment with another investigational agent within 30 days before study entry, judged by the investigator.
- Severe gastrointestinal disease, including gastroparesis. As judged by the investigator.
- Body mass index (BMI) \> 40 kg/m2.
- 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.
- 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).
- Current drug and alcohol abuse.
- History of acute or chronic pancreatitis
- Subjects considered by the investigator to be unsuitable for the study.
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Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01425580
Start Date
January 1 2012
End Date
August 1 2016
Last Update
September 1 2016
Active Locations (2)
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1
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Stockholm, Sweden, 118 83
2
Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB
Stockholm, Sweden, 118 83