Effects on subclinical heartfailure in type 2 diabetic subjects on liraglutide treatment versus glimepiride both in combination with metformin. - Liraglutide and heartfailure

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.