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

NCT ID: NCT01386671

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-01-31

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.

Detailed Description

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Metformin glycinate

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Metformin hydrochloride

Intervention Type: 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).

Interventions

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

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Predial

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Silanes S.A. de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels H Wacher, PhD

Role: PRINCIPAL_INVESTIGATOR

IMSS

Locations

Paracelsus S.A. de C.V.

Mexico City, AA, Mexico

Unidad Antidiabética Integral

Mexico City, AA, Mexico

Instituto de terapéutica experimental y clínica (INTEC)

Guadalajara, Jalisco, Mexico

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

Mexico City, Mexico City, Mexico

Countries

Mexico

References

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.

Reference Type: BACKGROUND

PMID: 20388897 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7895460 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15787679 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9742977 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18784090 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19959591 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18955635 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18955637 (View on PubMed)

Other Identifiers

GlyMet01_13062011

Identifier Type: -

Identifier Source: org_study_id