Phase 4 N=49 Randomized Quadruple-blind Treatment

Effects of Linagliptin on Endothelial Function

Type 2 Diabetes · Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT02350478 ↗

Enrolled (actual)

Serious AEs

9.3%

Results posted

Dec 2019

Primary outcome: Primary: Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks — 0.4; -0.5 percentage of change in diameter (%)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Linagliptin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Medical University of Graz
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks	0.4; -0.5	—
SECONDARY Changes in Global Arginine Bioavailability Ratio (Ratio of Arginine to [Ornithine + Citrulline]) and Arginine to Ornithine Ratio From Baseline to 12 Weeks	-0.11; -0.06; -0.13; -0.05	—
SECONDARY Changes in Biochemical Markers (sICAM-1)	-15; -21	—
SECONDARY Changes in the Area Under Curve (AUC) of Glucose, Insulin and C-peptide During the Meal Tolerance Test From Baseline to 12 Weeks	-1135; 481; -3; -34; 249; 40	—
SECONDARY Changes in the Area Under Curve (AUC) of Free Fatty Acids During the Meal Tolerance Test From Baseline to 12 Weeks	2.0; -3.1	—
SECONDARY Changes in Biochemical Markers (svCAM-1)	-34; 5	—

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.

Eligibility 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02350478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.