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Clinical Trial Details

Trial ID: L0409
Source ID: NCT01617824
Associated Drug: Linagliptin
Title: Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Chronic Renal Failure
Interventions: DRUG: Linagliptin|DRUG: Placebo
Outcome Measures: Primary: M1/M2 polarization balance, Evaluate whether 4-days Linagliptin treatment, compared to placebo, significantly reduces the M1/M2 ratio in type 2 diabetic patients. In this cross-over design trial, Linagliptin and placebo will be administered once daily for 4 consecutive days to 30 type 2 diabetic patients with or without renal failure with a 2 week washout period in between., day 5 | Secondary: Cytokine and chemokine concentrations, Evaluate whether 4-days Linagliptin treatment, compared to placebo, significantly modifies the concentrations of selected cytokines and chemokines (MCP-1, RANTES, SDF-1a, IL-1, IL-6, TNF-a, IL-10, TGF-beta, CCL22, fraktalkine) in type 2 diabetic patients. In this cross-over design trial, Linagliptin and placebo will be administered once daily for 4 consecutive days to 30 type 2 diabetic patients with and without renal failure with a 2 week washout period in between. As the number of measures is high and there is no adjustment for multiple testing, this outcome is to be considered exploratory., day 5|Endothelial progenitor cell levels, Evaluate whether 4-days Linagliptin treatment, compared to placebo, significantly modifies the levels of CD34+KDR+ EPCs (outcome added in course), day 5
Sponsor/Collaborators: Sponsor: University of Padova
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 45
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2012-09
Completion Date: 2014-12
Results First Posted:
Last Update Posted: 2014-12-19
Locations: University Hospital Diabetes Outpatient Clinic, Padova, 35100, Italy
URL: https://clinicaltrials.gov/show/NCT01617824