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

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ClinicalTrials.gov Identifier: NCT01386671
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Metformin glycinate Drug: Metformin hydrochloride Phase 3

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  (Clinical Trial)
Actual Enrollment : 203 participants
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
Actual Study Start Date : June 2014
Primary Completion Date : February 2016
Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Predial



Primary Outcome Measures :
  1. 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 :
  1. Fasting glucose [ Time Frame: 12 months ]
  2. Total cholesterol [ Time Frame: 12 months ]
  3. High-density lipoprotein (HDL) [ Time Frame: 12 months ]
  4. Low-density lipoprotein (LDL) [ Time Frame: 12 months ]
  5. Triglycerides [ Time Frame: 12 months ]
  6. Tumor necrosis factor-alpha (TNF-α) [ Time Frame: 12 months ]
  7. Adiponectin [ Time Frame: 12 months ]
  8. Resistin [ Time Frame: 12 months ]
  9. Interleukin-1 beta (IL-1β) [ Time Frame: 12 months ]
  10. Number of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]
  11. Malonylaldehyde [ Time Frame: 12 months ]
  12. Dismutase superoxide [ Time Frame: 12 months ]


Information from the National Library of Medicine

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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
  • 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.

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 Antidiabética Integral
Mexico City, AA, Mexico, 06600
Paracelsus S.A. de C.V.
Mexico, city, AA, Mexico, 03800
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, 06720
Instituto de terapéutica experimental y clínica (INTEC)
Guadalajara, Jalisco, Mexico, 44600
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
Principal Investigator: Niels H Wacher, PhD IMSS

Publications:

Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01386671     History of Changes
Other Study ID Numbers: GlyMet01_13062011
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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