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Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early Diabetes

NCT02015299 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-05-18

No results posted yet for this study

Summary

Diabetes is associated with an increased risk for developing premature macrovascular complications. The process of irreversible subclinical damage to the vasculature already starts during its preceding stages. Dipeptidyl peptidase (DPP)-4 inhibitors have been shown to attenuate vascular damage in preclinical studies. Off-target effects on adipose tissue inflammation, liver steatosis and atherosclerotic plaques have been extensively documented in animal studies.

Based on these considerations the investigators hypothesize that early therapy with the DPP4 inhibitor linagliptin in subjects with treatment naive type 2 diabetes will lead to beneficial effects on arterial stiffness as measured by pulse wave velocity.

Conditions

Interventions

DRUG

Linagliptin

one tablet linagliptin 5 mg/day for 26 weeks

DRUG

placebo

one tablet matching placebo/day for 26 weeks

Sponsors & Collaborators

Principal Investigators

  • Pieter W Kamphuisen, MD PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015299 on ClinicalTrials.gov