The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2 diabetes patients, in a 12 months follow up.
Metformin glycinate salt is a new drug , which has better pharmacokinetic characteristics (better bioavailability and absorption) making a proper antihyperglycemic power without increasing the frequency of adverse effects. The drug has been tested in preclinical test with animals, in healthy subjects and in patients with type 2 diabetes; which showed that it has adequate antihyperglycemic effect. Now, its important to compare metformin glycinate and metformin hydrochloride for evaluate the relative antihyperglicemic power. In addition, a study with a larger number of patients improve the statistical power of the test to investigate the effects of these drugs on possible weight loss and lipid profile improve. Additionally, it will also explore the relative power of the two medications tested to modify inflammatory response mediators and oxidative stress have been associated with the incidence of cardiovascular disease in diabetes. This project was designed with the intent to answer the next question: What are the efficacy and safety of metformin glycinate dose of 2101.2 mg/day (equivalent to 1700 mg/day metformin hydrochloride), compared with metformin hydrochloride in doses of 1700 mg/day for 12 months of treatment in patients with Type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
203
Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily
12 months: 1 month, once daily dose of 850 mg (before dinner) and 11 months, twice daily dose 850 mg (before breakfast) + 850 mg (before dinner).
Paracelsus S.A. de C.V.
Mexico City, AA, Mexico
Unidad Antidiabética Integral
Mexico City, AA, Mexico
Instituto de terapéutica experimental y clínica (INTEC)
Guadalajara, Jalisco, Mexico
Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social
Mexico City, Mexico City, Mexico
Glycosylated hemoglobin (HbA1c)
HbA1c: Measured by electrophoresis of lacked total blood using Paragon system and Appraise reader 44800 (Beckman Instruments de Mexico). Fasting Glucose: in serum using glucose oxidase technique with BM/Hitachi 704/911 automated analyzer
Time frame: 12 months
Fasting glucose
Time frame: 12 months
Total cholesterol
Time frame: 12 months
High-density lipoprotein (HDL)
Time frame: 12 months
Low-density lipoprotein (LDL)
Time frame: 12 months
Triglycerides
Time frame: 12 months
Tumor necrosis factor-alpha (TNF-α)
Time frame: 12 months
Adiponectin
Time frame: 12 months
Resistin
Time frame: 12 months
Interleukin-1 beta (IL-1β)
Time frame: 12 months
Number of Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 months
Malonylaldehyde
Time frame: 12 months
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Dismutase superoxide
Time frame: 12 months