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Clinical Trial Details

Trial ID: L2329
Source ID: NCT04392557
Associated Drug: Metformin / Alogliptin Oral Product
Title: Anti-inflammatory Status in DM2 Treated Patients
Acronym: INF-DM2-Ther
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin / alogliptin Oral Product|DRUG: Metformin / Pioglitazone Pill|DRUG: triple therapy
Outcome Measures: Primary: inflammatory miRNA, Change from Baseline at 12 months, 12 months|side effects, statistically significant difference (P\<0.05) in the development of side effects between the groups, recorded using the Naranjo adverse drug reactions scale, 12 months | Secondary: body weight, effects of each treatment on body mass index (kg/m\^2) (as indirect indexes of systemic inflammation and visceral adiposity)., 12 months|Waist values, effects of each treatment on waist values (cm) (as indirect indexes of systemic inflammation and visceral adiposity)., 12 months|drug interaction, statistically significant difference (P\<0.05) in the development of drug-drug interactions, recorded using the DIPS scale, 12 months|Fasting blood glucose, effects of each treatment on fasting blood glucose (mg/dL) (as indexes of glucose metabolism);, 12 months|HbA1c levels, effects of each treatment on HbA1c levels (percent) (as indexes of glucose metabolism);, 12 months|liver function, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl-transpeptidase levels, and total bilirubin levels (expressed as mg/dL) (as indexes of liver function)., 12 months|cell count, effects of each treatment on white blood cell count expressed as cell/mm3 (as direct index of systemic inflammation), 12 months|lipid metabolism/atheroscelorisis, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides levels (expressed as mg/dL) (as direct indexes of lipid metabolism and atheroscelorisis)., 12 months
Sponsor/Collaborators: Sponsor: University of Catanzaro
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-07-01
Completion Date: 2021-06-20
Results First Posted:
Last Update Posted: 2020-09-16
Locations: ASP Catanzaro, Catanzaro, 88100, Italy
URL: https://clinicaltrials.gov/show/NCT04392557