drugset / Trial / NCT04392557

Anti-inflammatory Status in DM2 Treated Patients

NCT04392557

Phase 4 Unknown 36 enrolled University of Catanzaro
RandomizedParallel-groupSingle-blindTreatment

Summary

Diabetes mellitus Type 2 (DMT2) - a progressive insulin secretory defect on the background of insulin resistance - is one of the major risk factors for atherosclerosis, an inflammatory disease of the arterial wall, in which leukocytes and oxidized lipoproteins accumulate leading to formation of fatty streaks and atherosclerotic plaques. Atherosclerosis accounts for more than 600,000 deaths annually in the U.S. mainly due to acute myocardial infarction and stroke. Pharmacological therapy of DMT2 includes several drugs used as monotherapy, although combination therapy between metfomin plus thiazolidinediones (TZD) and/or dipeptidyl-peptidase 4 inhibitors (DPP4I) plus TDZ, may delay atherosclerosis progression even if the molecular mechanisms are not clear. Even if normoglycemia is achieved, DMT2 patients still displayed a higher risk for developing atherosclerosis suggesting that other mechanisms of the inflammatory status are involved

Timeline

Start
2020-07-01
Primary completion
2020-09-01
Completion
2021-06-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alogliptin Unknown 12.5 mg Oral
Comparator Metformin Small molecule 850 mg Oral
Comparator Metformin Small molecule 1000 mg Oral
Comparator Pioglitazone Small molecule 15 mg Oral