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

January 26, 2018 updated by: Laboratorios Silanes S.A. de C.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • AA
      • Mexico City, AA, Mexico, 06600
        • Unidad Antidiabética Integral
      • Mexico, city, AA, Mexico, 03800
        • Paracelsus S.A. de C.V.
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06720
        • Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Instituto de terapéutica experimental y clínica (INTEC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Active Comparator: 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.
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).
Other Names:
  • Predial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated hemoglobin (HbA1c)
Time Frame: 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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Niels H Wacher, PhD, IMSS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

June 30, 2011

First Posted (Estimate)

July 1, 2011

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlyMet01_13062011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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