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Clinical Trial Details

Trial ID: L5447
Source ID: NCT02015299
Associated Drug: Linagliptin
Title: Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early Diabetes
Acronym: RELEASE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Linagliptin|DRUG: placebo
Outcome Measures: Primary: change from baseline carotid-(right) femoral arterial Pulse Wave Velocity (PWV) at 26 weeks, baseline, week 26 | Secondary: Secondary vascular study parameters, * Central Blood Pressure (CBP) and Augmentation Index (AI) obtained from pulse wave analysis, using Sphygmocor * Carotid-(left) radial arterial PWV, using Sphygmocor, baseline, week 4, week 26, and 4 weeks after treatment discontinuation (week 30)|Subclinical vascular inflammation (FDG PET-CT), Target-to-background ratios (TBRs) (18)F-fluorodeoxyglucose positron emission tomography computed tomography coregistration (FDG PET-CT), 26 weeks | Other: Body Mass Index and Waist-to-Hip ratio, Body Mass Index and Waist-to-Hip ratio, baseline, week 4, week 26, and 4 weeks after treatment discontinuation (week 30)|Blood pressure, 24-hours ambulatory blood pressure measurement (24-ABPM), baseline, week 4, week 26, and 4 weeks after treatment discontinuation (week 30)|Advanced glycation end products, Skin AGE deposition measured and plasma levels of AGEs, baseline, week 4, week 26, and 4 weeks after treatment discontinuation (week 30)|plasma markers of inflammation, baseline, week 26|plasma markers of endothelial dysfunction, baseline, week 26|Glycemic indices, Fasting glucose (FPG) and 2-hour post OGTT glucose (OGTT), HbA1c, baseline, week 4, week 26, and 4 weeks after treatment discontinuation (week 30)|albuminuria, Urinary albumin/creatinine ratio, baseline, week 4, week 26, and 4 weeks after treatment discontinuation (week 30)|Lifestyle, Intake of energy, Eating behaviour, and Physical activity, baseline, week 26
Sponsor/Collaborators: Sponsor: dr. DJ Mulder | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 45
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-03
Completion Date: 2016-03
Results First Posted:
Last Update Posted: 2016-05-18
Locations: University Medical Center Groningen, Groningen, 9700 RB, Netherlands
URL: https://clinicaltrials.gov/show/NCT02015299