Effects of Linagliptin on Endothelial Function

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is planned to evaluate if linagliptin can improve endothelial function in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on arginine bioavailability ratios and postchallenge glycaemic control will be studied.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Linagliptin

Criteria

Inclusion Criteria:

• Age: 40 to 80 years

• Early diabetes (postchallenge diabetes (2h glucose >200 mg/dl or type 2 diabetes treated with diet only or on a stable dose of metformin monotherapy)

• Coronary atherosclerosis (diagnosed via coronary angiography or coronary computer tomography)

Exclusion Criteria:

• Acute coronary syndrome or cerebrovascular event within the previous 4 weeks

• Body Mass Index (BMI) > 35 kg/m2

• HbA1c <6.0% (42 mmol/mol)

• Serum creatinine > 2.5 mg/dl

• Aspartate Transaminase (AST)/Alanine Transaminase (ALT)>3x upper limit of normal

• HbA1c >9.0% (>75 mmol/mol)

• Heart failure > New York Heart Association (NYHA) class II

• Uncontrolled hypertension (blood pressure > 165 / 100 mmHg)

• Treatment with orally administered steroids

• New onset statin or Angiotensin Converting Enzym- (ACE-) inhibitor within the previous 6 weeks

• Known Malignancy

• Pregnancy or breast feeding women.