Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Laboratorios Silanes

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin Hydrochloride; Drug: Metformin glycinate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02064881

DMMET_LP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

metformin glycinate

Experimental group

Description:

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.

Treatment:

Drug: Metformin glycinate

metformin hydrochloride

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin Hydrochloride