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Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes

NCT04943692 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-06-29

No results posted yet for this study

Summary

Phase III study to evaluate the efficacy and safety of the treatment. Two-arm, prospective, longitudinal, double-blind, multicenter randomized clinical trial.

Conditions

Interventions

DRUG

Metformin glycinate

1050 mg, tablets Administered orally, twice a day, for 12 months.

DRUG

Metformin Hydrochloride

850 mg, tablets. Administered orally, twice a day, for 12 months.

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Guillermo Fanghänel Salmón, M.D · Clinica integral del paciente diabético y obeso

  • Manuel González Ortiz, M.D · Instituto de terapéutica experimental y clínica (INTEC)

  • Joel Rodríguez Saldaña, M.D · Resultados médicos, desarrollo e investigación SC. (REMEDI)

  • María L Sánchez Aldana Robles, M.D · Investigación Biomédica para el Desarrollo de Fármacos, S.A de C.V. (IBIOMED-GDL)

  • Francisco G Padilla Padilla, M.D · Independent

  • Jorge V Yamamoto Cuevas, M.D · Clínica Villa Coapa La Vereda S.C.

  • Edmundo D Ríos Mejía, M.D · Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (IBIOMED-AGS)

  • Luis M Román Pintos, M.D · Hospital Hispanos S.A. de C.V.

  • Víctor Bohórquez López, M.D · Oaxaca Site Management Organization SC. (Red OSMO)

  • Santiago P Ramírez Díaz, M..D · Centro de Investigación Médica Aguascalientes (Red OSMO)

  • José De la Cruz Tun Pech, M.D · Mérida Investigación Clínica (Red OSMO)

  • Fernando J Lavalle González, M.D · Servicio de endocrinología Hospital Univertsitario, UANL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943692 on ClinicalTrials.gov