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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin glycinate; Drug: Metformin hydrochloride

• Registration Number: NCT01386671
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-01
• Study Start: 2014-06
• Primary Completion: 2016-02
• Status Verified: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin glycinate	Metformin glycinate	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.
Metformin Hydrochloride	Metformin hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Glycosylated hemoglobin (HbA1c)	12 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Unidad Antidiabética Integral; 🇲🇽 Mexico City, AA, Mexico

Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social; 🇲🇽 Mexico City, Distrito Federal, Mexico

Instituto de terapéutica experimental y clínica (INTEC); 🇲🇽 Guadalajara, Jalisco, Mexico

Paracelsus S.A. de C.V.; 🇲🇽 Mexico, city, AA, Mexico