Aim: This study evaluated the effect of metformin glycinate on glycated hemoglobin A1c (A1C) concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus (T2DM).
Subjects and methods: A randomized, double-blind, placebo-controlled clinical trial was carried out in 20 patients with drug-naive T2DM. Ten subjects received metformin glycinate (1,050.6 mg) once daily during the first month and force-titrated twice daily during the second month. Ten additional patients received placebo as the control group. Before and after the intervention, metabolic profile including A1C and insulin sensitivity (euglycemic-hyperinsulinemic clamp technique) was estimated.
Results: A1C concentrations decreased significantly with metformin glycinate administration (8.0 ± 0.7% vs. 7.1 ± 0.9%, P = 0.008) before and after the intervention, respectively. There were significant differences in changes from baseline of A1C between groups (0.0 ± 0.7% vs. -1.0 ± 0.5% for placebo and metformin glycinate groups, respectively; P = 0.004). A reduction of ≥1% in A1C levels was reached in 60.0% of patients with metformin glycinate administration (P = 0.02). Insulin sensitivity was not modified by the intervention.
Conclusions: Administration of metformin glycinate during a 2-month period showed a greater decrease in A1C concentrations than placebo in a selected group of drug-naive adult patients with T2DM.
Trial registration: ClinicalTrials.gov NCT00940797.