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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01386671
First received: June 29, 2011
Last updated: February 19, 2014
Last verified: February 2014

June 29, 2011
February 19, 2014
August 2011
June 2016   (final data collection date for primary outcome measure)
Glycosylated hemoglobin (HbA1c) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

Same as current
Complete list of historical versions of study NCT01386671 on ClinicalTrials.gov Archive Site
  • Fasting glucose [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Total cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • High-density lipoprotein (HDL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Low-density lipoprotein (LDL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Tumor necrosis factor-alpha (TNF-α) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Resistin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Interleukin-1 beta (IL-1β) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Malonylaldehyde [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Dismutase superoxide [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
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 drug naïve type 2 diabetes patients, in a 12 months follow up.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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).
  • Experimental: Metformin glycinate
    Intervention: Drug: Metformin glycinate
  • Active Comparator: Metformin Hydrochloride
    Intervention: Drug: Metformin hydrochloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
October 2016
June 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01386671
GlyMet01_13062011
No
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.
February 2014

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