Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Phase 2

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients of both sexes
Between 35 and 65 years old
Patients with type 2 diabetes within two years of diagnosis according to the ADA criteria
Overweight patients (BMI between 25.5 and 29.9 kg/m2) or with grade 1 obesity (BMI between 30.0 and 34.9 kg/m2), according to WHO classification
Low HDL levels: <50 in women and <40 mg/dL in men
Hypertriglyceridemia: >150 and less than 300 mg/dL
Patients who had not taken antidiabetes drug treatment or with diet and exercise treatment, or with metformin or DPP4 inhibitor monotherapy
HbA1c between 6.5 and 8.5%.
Creatinine clearance >60 ml/min (calculated by Cockcroft and Gault)
Informed consent form signed.
Women using contraception.

Exclusion Criteria

Patients with other types of diabetes (type 1, LADA, MODY, etc.).
Patients with primary dyslipidemia.
Patients with poorly substituted hypothyroidism TSH > 5 mU/mL.
Patients hospitalized in the last month.
Patients with a disease of poor short-term prognosis
Patients with autoimmune or rheumatic diseases.
Patients with acute infection or febrile illness.
History of chronic liver disease or ALT or AST ≥ 2.0 times the upper limit of normal, or GGT ≥ 3 times the upper limit of normal.
Patients with any other chronic disease, for example: HIV, rheumatic diseases.
Pregnant or positive pregnancy test.
Women who are breastfeeding.
Patients in another research project.

Arm && Interventions

Group	Intervention	Description
metformin hydrochloride	Metformin Hydrochloride	500mg tablets of metformin hydrochloride:1 tablet by mouth at night for 3 days, 1 tablet in the morning and evening for 3 days, 1 tablet in the morning and 2 tablets in the evening for 3 days and 2 tablets in the evening and 2 tablets in the morning until the end of the study. Total study dose: 1000mg every 12 hours.
metformin glycinate	Metformin glycinate	620mg tablets of metformin glycinate: 1 tablet by mouth at night for 3 days, 1 tablet in the morning and evening for 3 days, 1 tablet in the morning and 2 tablets in the evening for 3 days and 2 tablets in the evening and 2 tablets in the morning until the end of the study. Total study dose: 1240mg every 12 hours.

Primary Outcome Measures

Name	Time	Method
Change in postprandial lipemia at 4 months	baseline, 4 months

Secondary Outcome Measures

Name	Time	Method
Change in FGF-21 levels at 4 months	baseline, 4 months
Change in uric acid at 4 months	baseline, 4 months
Number of Participants with Serious and Non-Serious Adverse Events	up to 4 months
Change in oxidized LDL at 4 months	baseline, 4 months
Change in A1C at 4 months	baseline, 4 months
Change in alanine aminotransferase at 4 months	baseline, 4 months

Locations (1): Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán
🇲🇽
México, Distrito Federal, Mexico