Effects of Linagliptin on Endothelial Function

NCT02350478 | Completed Phase 4 Results DMC

• 1 other identifier: HS-2012-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks

  Endothelium-dependent FMD following reactive hyperaemia was examined in the brachial artery according to the guidelines described by Coretti et al (J Am Coll Cardiol. 2002;39(2):257-65). FMD-diameter is calculated as the average of the three diameter measurements following reactive hyperaemia. FMD was calculated as the percent change in diameter compared to baseline. Flow-mediated dilation is reported such as "percentage of change in diameter (%)".

  12 weeks

Secondary Outcomes (5)

• Changes in Global Arginine Bioavailability Ratio (Ratio of Arginine to [Ornithine + Citrulline]) and Arginine to Ornithine Ratio From Baseline to 12 Weeks

  12 weeks

• Changes in Biochemical Markers (sICAM-1)

  12 weeks

• Changes in the Area Under Curve (AUC) of Glucose, Insulin and C-peptide During the Meal Tolerance Test From Baseline to 12 Weeks

  12 weeks

• Changes in the Area Under Curve (AUC) of Free Fatty Acids During the Meal Tolerance Test From Baseline to 12 Weeks

  12 weeks

• Changes in Biochemical Markers (svCAM-1)

  12 weeks

Study Arms (2)

Linagliptin

ACTIVE COMPARATOR

The subjects will receive Linagliptin 5mg (licensed dose for treatment of type 2 diabetes) .

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

The subjects will receive placebo.

Drug: Placebo

Interventions

Linagliptin DRUG

The subject will receive Linagliptin 5mg orally once daily for 12 weeks.

Also known as: Trajenta

Linagliptin

Placebo DRUG

The subject will receive placebo orally once daily for 12 weeks.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz, Department for Internal Medicine

Graz, 8036, Austria

Location

Related Publications (2)

• Tripolt NJ, Aberer F, Riedl R, Url J, Dimsity G, Meinitzer A, Stojakovic T, Aziz F, Hodl R, Brachtl G, Strunk D, Brodmann M, Hafner F, Sourij H. Effects of linagliptin on endothelial function and postprandial lipids in coronary artery disease patients with early diabetes: a randomized, placebo-controlled, double-blind trial. Cardiovasc Diabetol. 2018 May 17;17(1):71. doi: 10.1186/s12933-018-0716-x.

  PMID: 29773079 DERIVED

• Tripolt NJ, Aberer F, Riedl R, Hutz B, Url J, Dimsity G, Meinitzer A, Stojakovic T, Hodl R, Brodmann M, Hafner F, Sourij H. 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. Trials. 2016 Oct 13;17(1):495. doi: 10.1186/s13063-016-1627-3.

  PMID: 27733180 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

Linagliptin; Sugars

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Carbohydrates

Results Point of Contact

• Title: Assoz.-Prof. Dr. Harald Sourij
• Organization: Medical University of Graz

ha.sourij@medunigraz.at

+43316385

Study Officials

• Harald Sourij, Assoc.-Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 29, 2015
• Study Start: July 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 15, 2020
• Results First Posted: December 16, 2019

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)