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

June 21, 2021 updated by: Laboratorios Silanes S.A. de C.V.
Phase III study to evaluate the efficacy and safety of the treatment. Two-arm, prospective, longitudinal, double-blind, multicenter randomized clinical trial.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Study to evaluate the efficacy and safety of treatment at 6 and 12 months with metformin glycinate at a dose of 2100 mg / day compared to metformin hydrochloride at a dose of 1700 mg / day on the progression of type 2 diabetes. To assess the change in HbA1c from baseline to 6 and 12 months of treatment (primary endpoint) in both groups. As secondary objectives, changes in fasting glucose levels from baseline, changes in results of the oral glucose tolerance test 2h from baseline, changes in HOMA-IR from baseline, changes in insulin levels, leptin, adipokines and proinflammatory cytokines, MCP-1, nitric oxide and PCr from baseline, changes in BMI from baseline and changes in lipid profile from baseline will be evaluated. A blinded interim analysis will be performed at 6 months of patient follow-up and a final analysis. Demographic data will be analyzed with mean, standard deviation, minimum and maximum. Efficacy analyzes will be carried out in the treated population (all treated patients, ATP), made up of all randomized patients who received at least one dose of the study treatment and who have a baseline measurement and at least one subsequent measurement.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Laboratorio Silanes, S.A. de C.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects ≥18 years old.
  • 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:

  • Patients with known current abuse or dependence (last 2 months) to substances such as alcohol (weekly consumption> 21 units of alcohol in men or> 14 units of alcohol in women) or recreational drugs.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Metformin glycinate 1050 mg
Metformin glycinate 1050 mg Orally twice a day.
Drug: Metformin glycinate
1050 mg, tablets Administered orally, twice a day, for 12 months.
Other Names:
  • MET GLY
Active Comparator: Group B: Metformin hydrochloride 850 mg
Metformin hydrochloride 850mg Orally twice a day.
Drug: Metformin Hydrochloride
850 mg, tablets. Administered orally, twice a day, for 12 months.
Other Names:
  • MET HYD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Baseline, 6 and 12 months
Assess change in HbA1c
Baseline, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fasting glucose
Time Frame: Baseline, 6 and 12 months
Determine the change in fasting glucose levels
Baseline, 6 and 12 months
Change in the 2-hour oral glucose tolerance curve
Time Frame: Baseline, 6 and 12 months
Determine the change from baseline in the results of the 2-hour oral glucose tolerance curve
Baseline, 6 and 12 months
Changes to HOMA-IR (Homeostatic model assessment and Insulin resistance
Time Frame: Baseline, 6 and 12 months
Determine change in HOMA-IR
Baseline, 6 and 12 months
Changes in insulin levels
Time Frame: Baseline, 6 and 12 months
Determine the changes in insulin levels
Baseline, 6 and 12 months
Changes in leptin levels
Time Frame: Baseline, 6 and 12 months
Determine the changes in leptin levels
Baseline, 6 and 12 months
Changes in adipokine levels
Time Frame: Baseline, 6 and 12 months
Determine the changes in adipokine levels
Baseline, 6 and 12 months
Changes in proinflammatory cytokine
Time Frame: Baseline, 6 and 12 months
Determine the changes in proinflammatory cytokine
Baseline, 6 and 12 months
Changes in levels of MCP-1 (monocyte chemoattractant protein 1)
Time Frame: Baseline, 6 and 12 months
Determine the changes in levels of MCP-
Baseline, 6 and 12 months
Changes in nitric oxide levels
Time Frame: Baseline, 6 and 12 months
Determine changes in nitric oxide levels
Baseline, 6 and 12 months
Changes in C-reactive protein levels
Time Frame: Baseline, 6 and 12 months
Determine changes in C-reactive protein levels
Baseline, 6 and 12 months
Changes in body mass index
Time Frame: Baseline, 6 and 12 months
Determine changes in body mass index
Baseline, 6 and 12 months
Incidence of adverse events
Time Frame: Baseline, 6 and 12 months
Determine the incidence of adverse events that occurred during the study.
Baseline, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Francisco G Padilla Padilla, M.D, Independent
  • Principal Investigator: Guillermo Fanghänel Salmón, M.D, Clinica Integral del Paciente Diabético y Obeso
  • Principal Investigator: Manuel González Ortiz, M.D, Instituto de terapéutica experimental y clínica (INTEC)
  • Principal Investigator: Joel Rodríguez Saldaña, M.D, Resultados médicos, desarrollo e investigación SC. (REMEDI)
  • Principal Investigator: María L Sánchez Aldana Robles, M.D, Investigación Biomédica para el Desarrollo de Fármacos, S.A de C.V. (IBIOMED-GDL)
  • Principal Investigator: Jorge V Yamamoto Cuevas, M.D, Clínica Villa Coapa La Vereda S.C.
  • Principal Investigator: Edmundo D Ríos Mejía, M.D, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (IBIOMED-AGS)
  • Principal Investigator: Luis M Román Pintos, M.D, Hospital Hispanos S.A. de C.V.
  • Principal Investigator: Víctor Bohórquez López, M.D, Oaxaca Site Management Organization SC. (Red OSMO)
  • Principal Investigator: Santiago P Ramírez Díaz, M..D, Centro de Investigación Médica Aguascalientes (Red OSMO)
  • Principal Investigator: José De la Cruz Tun Pech, M.D, Mérida Investigación Clínica (Red OSMO)
  • Principal Investigator: Fernando J Lavalle González, M.D, Servicio de endocrinología Hospital Univertsitario, UANL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30000-III-19(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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