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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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



Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 29, 2011
Last Updated: February 19, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

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

ClinicalTrials.gov processed this record on September 22, 2014