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

NCT01386671 | Completed Phase 3

• 1 other identifier: GlyMet01_13062011
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 4

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; metformin glycinate; metabolic control

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin (HbA1c)

  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

  12 months

Secondary Outcomes (12)

• Fasting glucose

  12 months

• Total cholesterol

  12 months

• High-density lipoprotein (HDL)

  12 months

• Low-density lipoprotein (LDL)

  12 months

• Triglycerides

  12 months

Study Arms (2)

Metformin glycinate

EXPERIMENTAL

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

Metformin Hydrochloride

ACTIVE COMPARATOR

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

Interventions

Metformin glycinate DRUG

Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily

Metformin glycinate

Metformin hydrochloride DRUG

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).

Also known as: Predial

Metformin Hydrochloride

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (4)

Paracelsus S.A. de C.V.

Mexico City, AA, 03800, Mexico

Location

Unidad Antidiabética Integral

Mexico City, AA, 06600, Mexico

Location

Instituto de terapéutica experimental y clínica (INTEC)

Guadalajara, Jalisco, 44600, Mexico

Location

Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (8)

• Hermann LS, Schersten 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. doi: 10.1111/j.1464-5491.1994.tb00253.x.

  PMID: 7895460 BACKGROUND

• 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. doi: 10.1111/j.1464-5491.2005.01448.x.

  PMID: 15787679 BACKGROUND

• 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. doi: 10.1001/jama.2010.405.

  PMID: 20388897 BACKGROUND

• 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.

  PMID: 9742977 BACKGROUND

• 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. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.

  PMID: 18784090 BACKGROUND

• 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. doi: 10.1136/bmj.b4731.

  PMID: 19959591 BACKGROUND

• 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. doi: 10.1001/archinte.168.19.2070.

  PMID: 18955635 BACKGROUND

• 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. doi: 10.1001/archinte.168.19.2088.

  PMID: 18955637 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Niels H Wacher, PhD

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: January 1, 2018
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

ME (4)