NCT01386671

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

Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin glycinate	Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily
DRUG	Metformin hydrochloride	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).

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-02-01
• Completion: 2018-01-01
• First posted: 2011-07-01
• Last updated: 2018-01-30

Locations

4 sites across 1 country: Mexico