Metformin Glycinate on Metabolic Control and Inflammatory Mediators in DM2 Patients - Full Text View

Purpose

This study compares Metformin Glycinate versus Metformin Hydrochloride in metabolic control and inflammatory mediators in DM2 patients.

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 DM2 Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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:	February 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Metformin glycinate, diet, exercise	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).

Detailed Description:

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386671

Contacts

Contact: Niels Wacher, PhD	56276900 ext 21481	nwacher@hotmail.com
Contact: Jorge A Canudas, PhD	54 88 37 00 ext 3761	jgonzalez@silanes.com

Locations

Mexico
Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social	Not yet recruiting
Col. Doctores, Distrito Federal, Mexico, 06720
Principal Investigator: Niels H Wacher, PhD

Sponsors and Collaborators

Laboratorios Silanes S.A. de C.V.

Instituto Mexicano del Seguro Social

Investigators

Principal Investigator:

Niels H Wacher, PhD

IMSS

More Information

Publications:

Alexander GC, Sehgal NL, Moloney RM, Stafford RS. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med. 2008 Oct 27;168(19):2088-94.

Hermann LS, Scherstén B, Melander A. Antihyperglycaemic efficacy, response prediction and dose-response relations of treatment with metformin and sulphonylurea, alone and in primary combination. Diabet Med. 1994 Dec;11(10):953-60.

Johnson JA, Simpson SH, Toth EL, Majumdar SR. Reduced cardiovascular morbidity and mortality associated with metformin use in subjects with Type 2 diabetes. Diabet Med. 2005 Apr;22(4):497-502.

Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010 Apr 14;303(14):1410-8.

[No authors listed] Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65. Erratum in: Lancet 1998 Nov 7;352(9139):1557.

Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. Epub 2008 Sep 10.

Tzoulaki I, Molokhia M, Curcin V, Little MP, Millett CJ, Ng A, Hughes RI, Khunti K, Wilkins MR, Majeed A, Elliott P. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ. 2009 Dec 3;339:b4731.

Selvin E, Bolen S, Yeh HC, Wiley C, Wilson LM, Marinopoulos SS, Feldman L, Vassy J, Wilson R, Bass EB, Brancati FL. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008 Oct 27;168(19):2070-80. Review.

Responsible Party:	Niels H. Wacher Ph.D., Unidad de Investigación en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Medico Nacional Siglo XXI, IMSS
ClinicalTrials.gov Identifier:	NCT01386671 History of Changes
Other Study ID Numbers:	GlyMet01_13062011
Study First Received:	June 29, 2011
Last Updated:	June 30, 2011
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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

Metformin Glycinate on Metabolic Control and Inflammatory Mediators in DM2 Patients (COMET)