Phase 4
Completed N=49
Effects of Linagliptin on Endothelial Function
Source: ClinicalTrials.gov NCT02350478 ↗Enrolled (actual)
49
Serious AEs
9.3%
Results posted
Dec 2019
Primary outcomePrimary: Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks — 0.4; -0.5 percentage of change in diameter (%)
◆ Published Evidence
Emerging
16citations · ~2 / year
Effects of linagliptin on endothelial function and postprandial lipids in coronary artery disease patients with early diabetes: a randomized, placebo-controlled, double-blind trial.
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.
Linked Publications (2)
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Effects of linagliptin on endothelial function and postprandial lipids in coronary artery disease patients with early diabetes: a randomized, placebo-controlled, double-blind trial.
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The effects of linagliptin on endothelial function and global arginine bioavailability ratio in coronary artery disease patients with early diabetes: study protocol for a randomized controlled trial.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02350478) and the linked publication. 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. Informational only — not medical advice.