Type 2 Diabetes Clinical Trial
Official title:
Effect of Metformin Glycinate on Postprandial Lipemia, Glycemic Control and Oxidation Markers in Type 2 Diabetes Patients
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.
Main objective: To compare the effect of metformin glycinate with metformin hydrochloride
postprandial lipemia (area under the curve of triglycerides)
Study group
Tablets of 620 mg of metformin glycinate. Scaling: 1 tablet at night for 3 days, followed by
1 tablet in the morning and 1 tablet at night for 3 days, followed by 1 tablet in the morning
and 2 tablets in the evening for 3 days and finally, 2 tablets in the morning and 2 tablets
in the evening to complete the study. Final study dose 1240 mg every 12 hours.
Comparative group
500 mg tablets of metformin hydrochloride. Scaling: 1 tablet at night for 3 days, followed by
1 tablet in the morning and 1 tablet at night for 3 days, followed by 1 tablet in the morning
and 2 tablets in the evening for 3 days and finally, 2 tablets in the morning and 2 tablets
in the evening to complete the study. Final study dose 1000 mg every 12 hours.
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