Efficacy Study of Metformin Glycinate on Postprandial Lipemia (NCT02064881) | Clinical Trial Compass
UnknownPhase 2/3
Efficacy Study of Metformin Glycinate on Postprandial Lipemia
Mexico72 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.