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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.

June 29, 2011
July 1, 2011
January 30, 2018
June 2014
February 2016   (Final data collection date for primary outcome measure)
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

Metabolic Control (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

Complete list of historical versions of study NCT01386671 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Fasting glucose [ Time Frame: 12 months ]
  • Total cholesterol [ Time Frame: 12 months ]
  • HDL [ Time Frame: 12 months ]
  • LDL [ Time Frame: 12 months ]
  • Triglycerides [ Time Frame: 12 months ]
  • TNF-α [ Time Frame: 12 months ]
  • Adiponectin [ Time Frame: 12 months ]
  • Resistin [ Time Frame: 12 months ]
  • 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 ]
Not Provided
Not Provided
 
Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • 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
  • 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.
    Intervention: Drug: Metformin glycinate
  • 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.
    Intervention: Drug: Metformin hydrochloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
200
January 2018
February 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01386671
GlyMet01_13062011
No
Not Provided
Plan to Share IPD: Undecided
Laboratorios Silanes S.A. de C.V.
Laboratorios Silanes S.A. de C.V.
Not Provided
Principal Investigator: Niels H Wacher, PhD IMSS
Laboratorios Silanes S.A. de C.V.
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP