Efficacy Study of Metformin Glycinate on Postprandial Lipemia
Status:
Unknown status
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to evaluate the effect of metformin glycinate vs metformin
hydrochloride on postprandial lipemia. 72 patients will be included, they will be randomized
and assigned into one of the two treatment groups: metformin glycinate 1240 mg BID or
metformin hydrochloride 1000 mg BID (36 patients per group). The patients will be followed
for 4 months.
Blood count, blood chemistry, liver profile, lipid profile, HbA1c, apolipoprotein B, oxidized
LDL, fibroblast growth factor 21, leptin, adiponectin, C-reactive protein, free fatty acids,
fibrinogen, Goodpasture Binding Protein (GPBP) and antioxidant activity of plasma will be
measured at baseline and 4 months.
Additionally, after a structured meal, the following parameters will be measured: glucose,
insulin, triglycerides, apolipoprotein B and oxidized LDL. (baseline and 4 months).
Throughout the study adverse events will be documented.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran