Background: Metformin Glycinate (MG) is a recently developed drug with a different pharmacokinetic profile compared to Metformin Hydrochloride (MH); it also has additional signaling pathways to control hyperglycemia.
Objective: To compare efficacy, safety and effect on inflammatory mediators of MG versus MH treatment over 12 months in T2DM patients. Clinical Trials.gov: NCT01386671.
Methods: Controlled, randomized, double blind, multicenter. Group A was treated with 1,700 mg/day of MH and Group B with 2,101.2 mg/day of MG. Milliplex Map Human Cyokine, commercial ELISA kit, was used to determinate the following pro-inflammatory mediators: TNF-α, IL-1 β, IL-6, ICAM-1, VCAM-1, CRP and anti-inflammatory mediator: adipokine.
Results: 203 patients were randomized, 101 (Group A) and 102 (Group B). 144 patients had complete for inflammatory mediators evaluation, 73 in Group A and 71 in Group B. There were no differences in mean HbA1c and fasting glucose between groups. In Group B a bigger proportion of patients achieved the goal of HbA1c 7%, p= 0.030; each intra-group showed statistical decrease differences in pro-inflammatory mediators, p<0.05 and increase adiponectin levels, p<0.05. After six months, only 76% of patients in Group A achieved normal levels of leptin versus 91% in Group B (p=0.022). QUICK were evaluated to determine insulin resistance, in Group B at 6 months had higher decrease resistance (p=0.040). There were fewer treatment emergent adverse events in Group B (p= 0.03).
Conclusion: There were no differences in efficacy between groups (HbA1c). The difference on inflammatory mediators’ response was statistically significantly different after 6 months of treatment. There was higher proportion of patients treated with Metformin Glycinate with normal levels in leptin and resistin, which could be related to a lower insulin resistance (QUICK). Metformin Glycinate group showed a better safety profile.
J. González-Canudas: Employee; Self; Laboratorios Silanes.
CONACyT; Laboratorios Silanes
