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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Laboratorios Silanes S.A. de C.V..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01386671
First Posted: July 1, 2011
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Drug: Metformin glycinate Drug: Metformin hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin glycinate 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 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).

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386671


Locations
Mexico
Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social
Col. Doctores, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
Principal Investigator: Niels H Wacher, PhD IMSS
  More Information

Publications:

Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01386671     History of Changes
Other Study ID Numbers: GlyMet01_13062011
First Submitted: June 29, 2011
First Posted: July 1, 2011
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Laboratorios Silanes S.A. de C.V.:
Type 2 Diabetes
metformin glycinate
metabolic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs