Efficacy Study of Metformin Glycinate on Postprandial Lipemia

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Collaborator: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Treatments: Metformin

Criteria

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.