Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-08-31

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.

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Metformin glycinate

Intervention Type DRUG

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) .

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.

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride

Intervention Type DRUG

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)

Interventions

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Metformin glycinate

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) .

Intervention Type DRUG

Metformin Hydrochloride

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)

Intervention Type DRUG

Other Intervention Names

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DMMET-01 HCL MET

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No