Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes. (EGOFIP)

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Microvascular Dysfunction; Type 2 Diabetes

Treatments: Drug: Victoza

Study type: Interventional

Funder types: Other

Identifiers

NCT01931982

2012-005013-38 (EudraCT Number)

eudraCT: 2012-005013-38

Details and patient eligibility

About

The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion in the heart of patients with type 2 diabetes

Enrollment: 20 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes on monotherapy with metformin or sulfonylurea or combination therapy of metformin and sulfonylurea.
• Age: 25-75 years
• BMI>25 kg/m2
• HbA1c 6,0-10 %

Exclusion criteria

• Current treatment with insulin or Dipeptidyl peptidase IV inhibitor.
• Haemoglobin < 6.5 mmol/l
• Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography or regional dysfunction documented during dipyridamol stress-echocardiography. If stress test at baseline shows significant stenosis the patient will be excluded from the study.
• Allergy towards victoza ® (liraglutide ), Dipyridamol, Nitroglycerin or rescue medicine: Theophyllin
• Pregnancy
• Severe asthma
• Active cancer
• Severe co-morbidity with limited life-expectancy
• Estimated glomerular filtration rate (eGFR) <60 (measured at baseline)
• Severe hepatic co-morbidity
• Chronic alcohol abuse
• Heart failure with a left ventricular ejection fraction </= 45%
• Atrial fibrillation
• Chronic or previous acute pancreatitis
• Inflammatory bowel disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

victoza

Active Comparator group

Description:

The study is a cross over study. Patients randomised to start with victoza are treated with victoza for 10 weeks. After a wash out period of 2 weeks they cross over to 10 weeks of no treatment

Treatment:

Drug: Victoza

No treatment

No Intervention group