Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Metformin Glycinate on Postprandial Lipemia, Glycemic Control and Oxidation Markers in Type 2 Diabetes Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Metformin glycinate
* Drug: Metformin Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin glycinate<br>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. | Drug: Metformin glycinate<br>* All patients are going to begin the treatment with one tablet orally at night, 30 minutes before dinner (1 tablet of 620 mg glycinate metformin or one 500 mg tablet of metformin hydrochloride) and the dose will be administrated every 3 days to complete the dose of 2 tablets in the morning 30 minutes before breakfast and 2 tablets in the evening 30 minutes before dinner (1240 mg metformin glycinate every 12 hours or 1000 mg metformin hydrochloride every 12 hrs) .<br>* Other names: DMMET-01;|
| Active Comparator: metformin hydrochloride<br>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. | Drug: Metformin Hydrochloride<br>* All patients are going to begin the treatment with one tablet orally at night, 30 minutes before dinner (1 tablet of 620 mg glycinate metformin or one 500 mg tablet of metformin hydrochloride) and the dose will be administrated every 3 days to complete the dose of 2 tablets in the morning 30 minutes before breakfast and 2 tablets in the evening 30 minutes before dinner (1240 mg metformin glycinate every 12 hours or 1000 mg metformin hydrochloride every 12 hrs)<br>* Other names: HCL MET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postprandial lipemia at 4 months |  | baseline, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxidized LDL at 4 months |  | baseline, 4 months | 
| Change in FGF-21 levels 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 | 
| Change in uric acid at 4 months |  | baseline, 4 months | 
| Number of Participants with Serious and Non-Serious Adverse Events |  | up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial lipemia, Diabetes, Metformin glycinate, oxidized LDL