Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes
NCT ID: NCT04943692
Last Updated: 2021-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
500 participants
INTERVENTIONAL
2021-08-31
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Metformin glycinate 1050 mg
Metformin glycinate 1050 mg Orally twice a day.
Metformin glycinate
1050 mg, tablets Administered orally, twice a day, for 12 months.
Group B: Metformin hydrochloride 850 mg
Metformin hydrochloride 850mg Orally twice a day.
Metformin Hydrochloride
850 mg, tablets. Administered orally, twice a day, for 12 months.
Interventions
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Metformin glycinate
1050 mg, tablets Administered orally, twice a day, for 12 months.
Metformin Hydrochloride
850 mg, tablets. Administered orally, twice a day, for 12 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes according to ADA diagnostic criteria.
* Naive to treatment or who have previously been under oral hypoglycemic treatment (whatever it may be), as long as it has been suspended for a period of ≥6 weeks prior to the start of the study. - HbA1c ≥7.5% and \<10.0%.
* In the case of women of childbearing age and with an active sexual life, the use of birth control methods is required; any of the following are accepted: barrier (male or female condom), non-hormonal intrauterine device, or bilateral tubal obstruction.
* That you agree to participate in the study and give written informed consent.
Exclusion Criteria
* Body Mass Index \<20 kg / m2 and\> 35 kg / m2.
* Glomerular filtration estimated with the MDRD (Modification of Diet in Renal Disease) procedure through serum creatinine \<60 ml / min / 1.72 m2.
* History of chronic liver disease or ALT (alanine aminotransferase) and / or AST (aspartate aminotransferase) ≥ 2 times the upper limit of normal, or GGT (Gamma glutamyl transpeptidase) ≥3 times the upper limit of normal.
* Chronic lung disease, causing dyspnea equivalent to a functional class ≥3 (NYHA) or requiring oxygen supplementation.
* Use of drugs that interact with biguanides.
* Other chronic diseases that limit survival or are associated with chronic inflammation such as: cancer, leukemia, lymphoma, lupus erythematosus, asthma, rheumatoid arthritis, or HIV (human immunodeficiency virus) infection.
* Pregnancy or positive pregnancy test, as well as women who are breastfeeding.
18 Years
ALL
Yes
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Guillermo Fanghänel Salmón, M.D
Role: PRINCIPAL_INVESTIGATOR
Clinica integral del paciente diabético y obeso
Manuel González Ortiz, M.D
Role: PRINCIPAL_INVESTIGATOR
Instituto de terapéutica experimental y clínica (INTEC)
Joel Rodríguez Saldaña, M.D
Role: PRINCIPAL_INVESTIGATOR
Resultados médicos, desarrollo e investigación SC. (REMEDI)
María L Sánchez Aldana Robles, M.D
Role: PRINCIPAL_INVESTIGATOR
Investigación Biomédica para el Desarrollo de Fármacos, S.A de C.V. (IBIOMED-GDL)
Francisco G Padilla Padilla, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
Jorge V Yamamoto Cuevas, M.D
Role: PRINCIPAL_INVESTIGATOR
Clínica Villa Coapa La Vereda S.C.
Edmundo D Ríos Mejía, M.D
Role: PRINCIPAL_INVESTIGATOR
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (IBIOMED-AGS)
Luis M Román Pintos, M.D
Role: PRINCIPAL_INVESTIGATOR
Hospital Hispanos S.A. de C.V.
Víctor Bohórquez López, M.D
Role: PRINCIPAL_INVESTIGATOR
Oaxaca Site Management Organization SC. (Red OSMO)
Santiago P Ramírez Díaz, M..D
Role: PRINCIPAL_INVESTIGATOR
Centro de Investigación Médica Aguascalientes (Red OSMO)
José De la Cruz Tun Pech, M.D
Role: PRINCIPAL_INVESTIGATOR
Mérida Investigación Clínica (Red OSMO)
Fernando J Lavalle González, M.D
Role: PRINCIPAL_INVESTIGATOR
Servicio de endocrinología Hospital Univertsitario, UANL
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Countries
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References
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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.
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Other Identifiers
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SIL-30000-III-19(1)
Identifier Type: -
Identifier Source: org_study_id
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