Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments metformin glycinate, metformin hydrochloride
Phase phase 3
Sponsor Laboratorios Silanes S.A. de C.V.
Start date August 2011
End date June 2016
Trial size 200 participants
Trial identifier NCT01386671, GlyMet01_13062011

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 drug naïve type 2 diabetes patients, in a 12 months follow up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
(Active Comparator)
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).

Primary Outcomes

Measure
Glycosylated hemoglobin (HbA1c)
time frame: 12 months

Secondary Outcomes

Measure
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
Dismutase superoxide
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Type 2 diabetes according ADA - Less than a year of evolution since diagnosis - Antihyperglycemic pharmacological treatment - HbA1c between 7.1% and 9.0% - 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 - 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.

Additional Information

Official title Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Patients
Principal investigator Niels H Wacher, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Laboratorios Silanes S.A. de C.V..