Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators 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: Type 2 diabetes according ADA Less than a year of evolution since diagnosis Without antihyperglycemic pharmacological treatment HbA1c between 6.5% and 9.5% Stable weight during the last 6 months Body Mass Index ≥ 25 kg/m2 and <35kg/m2. Blood pressure ≤ 130/80 mmHg Childbearing women under contraceptive treatment Signed Informed Consent Form Age from 18 to 70 years old Exclusion Criteria: Non-fulfilment treatment in the screening period Smoking up to 1 year before the initial examination Drugs or alcohol abuse Creatinine depuration estimated with MDRD formula using serum creatinine < 90 ml/min/1.72m2 History of chronic liver disease, ALT or AST ≥ 2 times from the normal superior limit, or GGT ≥ 3 times from the normal superior limit. Chronic lung disease, that causes dyspnea equivalent to a functional class ≥3 (NYHA)or that requires oxygen supplementation. History or symptoms of coronary artery disease (CAD) or cerebrovascular disease (CVD). Drug treatment that interact with biguanides. Another chronic diseases that restricts survival or associated with chronic inflammation like: cancer, leukemia, lymphoma, erythematosus lupus, asthma, rheumatoid arthritis or infection for HIV. Pregnancy or positive pregnancy test in women under 50 years old or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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>Metformin glycinate is a new biguanide, for this study the dose administrated will be 1050.6 mg OD for a month, and 1050.6 mg BID for 11 moths. | Drug: Metformin glycinate<br>* Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily<br>|
| Active Comparator: Metformin Hydrochloride<br>Metformin Hydrochloride is the biguanide most used, for this study the dose administrated will be 850 mg OD for a month, and 850 mg BID for 11 months. | Drug: Metformin hydrochloride<br>* 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).<br>* Other names: Predial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose |  | 12 months | 
| Total cholesterol |  | 12 months | 
| High-density lipoprotein (HDL) |  | 12 months | 
| Low-density lipoprotein (LDL) |  | 12 months | 
| Triglycerides |  | 12 months | 
| Tumor necrosis factor-alpha (TNF-α) |  | 12 months | 
| Adiponectin |  | 12 months | 
| Resistin |  | 12 months | 
| Interleukin-1 beta (IL-1β) |  | 12 months | 
| Number of Adverse Events as a Measure of Safety and Tolerability |  | 12 months | 
| Malonylaldehyde |  | 12 months | 
| Dismutase superoxide |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, metformin glycinate, metabolic control