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Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2 (DMMETCOV19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04626089
Recruitment Status : Withdrawn (Administrative decision of the company)
First Posted : November 12, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 Metabolic Syndrome Type 2 Diabetes Drug: metformin glycinate Drug: Placebo oral tablet Phase 2

Detailed Description:
After being informed about the study and potential risks, all patients will give written informed consent and undergo a 1 day screening period to determine the eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind (participant and investigator) in a 1:1 ratio to metformin glycinate (620 mg, taken orally twice daily) plus standard treatment or placebo (taken orally,twice daily) plus standard treatment, both will be for 14 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental group: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days. Control Group: Placebo bid (PO) plus standard treatment for 14 days plus
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Parallel assignment experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number
Primary Purpose: Treatment
Official Title: Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: Metformin glycinate
620 mg bid (PO) plus standard treatment for 14 days
Drug: metformin glycinate
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
Other Name: DMMET

Placebo Comparator: Placebo
Placebo tablets bid (PO) plus standard treatment for 14 days
Drug: Placebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
Other Name: Placebo




Primary Outcome Measures :
  1. Viral Load [ Time Frame: Day 0 to Day 8 or patient discharge day ]
    Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate


Secondary Outcome Measures :
  1. Days of supplementary oxygen if apply [ Time Frame: Day 0 to day 28 or patient discharge day ]
    Assess length of supplementary oxygen

  2. Days of supplementary mechanical ventilation if apply [ Time Frame: Day 0 to day 28 or patient discharge day ]
    Assess length of mechanical ventilation

  3. Days of Hospitalization [ Time Frame: Day 0 to day 28 or patients discharge day ]
    Assess length of hospitalization

  4. Normalization of fever [ Time Frame: Day 0 to day 28 or patient discharge day ]
    Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate

  5. Normalization of oxigen saturation [ Time Frame: Day 0 to day 28 or patient discharge day ]
    Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate

  6. Number of deaths [ Time Frame: Day 0 to day 28 or patient discharge day ]
    Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate

  7. Change in Serum creatinine levels [ Time Frame: Day 0 to day 28 or patients discharge day ]
    Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl

  8. Change in serum Troponin I [ Time Frame: Day 0 to day 28 or patients discharge day ]
    Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l

  9. Change in serum aspartate aminotransferase levels [ Time Frame: Day 0 to day 28 or patients discharge day ]
    Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l

  10. Change in serum Creatine kinase-MB levels [ Time Frame: Day 0 to day 28 or patients discharge day ]
    Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l

  11. Incidence of adverse event [ Time Frame: Day 0 to day 28 or patients discharge day ]
    Assess by incidence of grade 3, grade 4 and Serious adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years old
  2. Ability to understand and the willingness to sign a written informed consent document before any study procedure
  3. Metabolic syndrome or type 2 diabetes
  4. Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
  5. Hospitalized patient.
  6. Radiographic evidence of pulmonary infiltrates

Exclusion Criteria:

  1. Participation in any other clinical trial of an experimental treatment for COVID-19
  2. Evidence of multi-organ failure
  3. Require mechanical ventilation before randomization
  4. Pregnant patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626089


Locations
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Mexico
Hospital Juárez de México, OPD
Mexico City, Mexico, 07760
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
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Principal Investigator: Fausto González-Villagrán, MD Hospital Juárez de México, OPD
Publications of Results:
González-Ortiz M, Martínez-Abundis E, Robles-Cervantes JA, Ramos-Zavala MG, Barrera-Durán C, González-Canudas J. Diabetes Technol Ther. 2012 Dec;14(12):1140-4. doi: 10.1089/dia.2012.0097. Epub 2012 Sep 13. Efficacy and Safety of Metformin Glycinate vs. Metformin Hydrochloride in Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Mellitus Patients (T2DM)
JORGE GONZÁLEZ-CANUDAS, COMET GROUP Diabetes Efficacy and Safety of Metformin Glycinate vs. Metformin Hydrochloride in Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Mellitus Patients. Diabetes 2019 Jun; 68(Supplement 1):
Garza-Ocañas L, Tamez-de la O E, Iglesias-Chiesa J, Gonzalez Canudas J, Rivas-Ruiz R: Pharmacokinetics and gastrointestinal tolerability of DMMET 01 (glycinate of metformin): results of a prospective randomized trial in healthy volunteers [abstract]. Diabetes 2009;58(Suppl 1):A533.
Food Chem Toxicol. 2019 Jan;123:470-480. doi: 10.1016/j.fct.2018.11.019. Epub 2018 Nov 9.
Dianben® 1000 mg polvo para solución oral. Ficha técnica del producto. Nº de autorización de comercialización: 70545. Merck Santé S.A.S. 37 rue Saint Romain. 69008 Lyon. Francia. Fecha de revision 2010. Consultada en la web de la Agencia Española del Medicamento y de Productos Sanitarios (www.aemps.gob.es) el 27 de Marzo del 2013

Other Publications:
Glucophage Product Monograph (metformin hydrochloride) Sanofi-Aventis Canada. Rev.28th October 2008
NDA 20-357, Glucophage. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
NDA 21-842, Actoplus met. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.

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Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT04626089    
Other Study ID Numbers: SIL-30000-II(1)
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Silanes S.A. de C.V.:
SARS-CoV 2
Metabolic Syndrome
Type 2 diabetes
Severe Acute Respiratory Syndrome
Metformin glycinate
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Diabetes Mellitus, Type 2
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs