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Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. (DMMETCOV19-2)

Primary Purpose

Severe Acute Respiratory Syndrome Coronavirus 2

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Metformin Glycinate
Placebo oral tablet
Sponsored by
Laboratorios Silanes S.A. de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2 focused on measuring SARS-COV 2, Severe acute respiratory syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization.
  4. Hospitalized
  5. 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
  5. Patients with kidney failure, cancer and among other conditions that due to their treatment and / or baseline condition, affect the distribution, bioavailability and elimination of the studied drug

Sites / Locations

  • The American British Cowdray Medical Center, I.A.P

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin glycinate

Placebo

Arm Description

620 mg bid (PO) for 14 days plus standard treatment

Placebo tablet bid (PO) for 14 days plus standard treatment

Outcomes

Primary Outcome Measures

Viral load
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
consciousness level
Clinical status assessed by measurement of consciousness level: alertness
temperature
Clinical status assessed by measurement of axillary body temperature in °C: <37.2.
systolic blood pressure
Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.
Oxigen saturation
Clinical status assessed by measurement of oxygen saturation in %: >90.
Heart rate
Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm.
respiratory rate
Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm,
Days of hospitalization
Assess length of hospitalization
Days of supplementary oxygen if applies
Assess length of supplementary oxygen
Days of supplementary mechanical ventilation
Assess length of mechanical ventilation

Secondary Outcome Measures

Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4)
Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)
Changes in laboratory test results
Changes in serum levels from security laboratories compared to baseline levels and between groups.

Full Information

First Posted
October 23, 2020
Last Updated
April 5, 2021
Sponsor
Laboratorios Silanes S.A. de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04625985
Brief Title
Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.
Acronym
DMMETCOV19-2
Official Title
Adaptive Study to Demonstrate Efficacy and Safety of Metformin Glycinate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Silanes S.A. de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1 day screening period to determine eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind manner (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 for 14 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome Coronavirus 2
Keywords
SARS-COV 2, Severe acute respiratory syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Experimental: Metformin glycinate 620 mg bid (PO) for 14 days plus standard treatment Control group: placebo bid (PO) for 14 days plus standard treatment Comparator: Placebo Placebo pill bid (PO) for 14 days plus standard treatment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Parallel Assignment Experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin glycinate
Arm Type
Experimental
Arm Description
620 mg bid (PO) for 14 days plus standard treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet bid (PO) for 14 days plus standard treatment
Intervention Type
Drug
Intervention Name(s)
Metformin Glycinate
Other Intervention Name(s)
DMMET
Intervention Description
Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment
Primary Outcome Measure Information:
Title
Viral load
Description
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Time Frame
Day 0 to Day 28 or patient discharge day
Title
consciousness level
Description
Clinical status assessed by measurement of consciousness level: alertness
Time Frame
Day 0 to Day 28 or patient discharge day
Title
temperature
Description
Clinical status assessed by measurement of axillary body temperature in °C: <37.2.
Time Frame
Day 0 to Day 28 or patient discharge day
Title
systolic blood pressure
Description
Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.
Time Frame
Day 0 to Day 28 or patient discharge day
Title
Oxigen saturation
Description
Clinical status assessed by measurement of oxygen saturation in %: >90.
Time Frame
Day 0 to Day 28 or patient discharge day
Title
Heart rate
Description
Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm.
Time Frame
Day 0 to Day 28 or patient discharge day
Title
respiratory rate
Description
Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm,
Time Frame
Day 0 to Day 28 or patient discharge day
Title
Days of hospitalization
Description
Assess length of hospitalization
Time Frame
Day 0 to Day 28 or patient discharge day
Title
Days of supplementary oxygen if applies
Description
Assess length of supplementary oxygen
Time Frame
Day 0 to Day 28 or patient discharge day
Title
Days of supplementary mechanical ventilation
Description
Assess length of mechanical ventilation
Time Frame
Day 0 to Day 28 or patient discharge day
Secondary Outcome Measure Information:
Title
Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4)
Description
Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)
Time Frame
Day 0 to Day 28 or patient discharge day
Title
Changes in laboratory test results
Description
Changes in serum levels from security laboratories compared to baseline levels and between groups.
Time Frame
Day 0 to Day 28 or patient discharge day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years old Ability to understand and the willingness to sign a written informed consent document before any study procedure Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization. Hospitalized Radiographic evidence of pulmonary infiltrates Exclusion Criteria: Participation in any other clinical trial of an experimental treatment for COVID-19 Evidence of multi-organ failure Require mechanical ventilation before randomization Pregnant patients Patients with kidney failure, cancer and among other conditions that due to their treatment and / or baseline condition, affect the distribution, bioavailability and elimination of the studied drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Silvia M Aguirre, MD
Organizational Affiliation
The American British Cowdray Medical Center. I.A.P.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The American British Cowdray Medical Center, I.A.P
City
Mexico City
ZIP/Postal Code
01120
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20380657
Citation
Fischer M, Timper K, Radimerski T, Dembinski K, Frey DM, Zulewski H, Keller U, Muller B, Christ-Crain M, Grisouard J. Metformin induces glucose uptake in human preadipocyte-derived adipocytes from various fat depots. Diabetes Obes Metab. 2010 Apr;12(4):356-9. doi: 10.1111/j.1463-1326.2009.01169.x.
Results Reference
background
PubMed Identifier
19538242
Citation
Cuthbertson J, Patterson S, O'Harte FP, Bell PM. Investigation of the effect of oral metformin on dipeptidylpeptidase-4 (DPP-4) activity in Type 2 diabetes. Diabet Med. 2009 Jun;26(6):649-54. doi: 10.1111/j.1464-5491.2009.02748.x.
Results Reference
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PubMed Identifier
12086935
Citation
Musi N, Hirshman MF, Nygren J, Svanfeldt M, Bavenholm P, Rooyackers O, Zhou G, Williamson JM, Ljunqvist O, Efendic S, Moller DE, Thorell A, Goodyear LJ. Metformin increases AMP-activated protein kinase activity in skeletal muscle of subjects with type 2 diabetes. Diabetes. 2002 Jul;51(7):2074-81. doi: 10.2337/diabetes.51.7.2074.
Results Reference
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PubMed Identifier
16308421
Citation
Shaw RJ, Lamia KA, Vasquez D, Koo SH, Bardeesy N, Depinho RA, Montminy M, Cantley LC. The kinase LKB1 mediates glucose homeostasis in liver and therapeutic effects of metformin. Science. 2005 Dec 9;310(5754):1642-6. doi: 10.1126/science.1120781. Epub 2005 Nov 24.
Results Reference
result
PubMed Identifier
11960602
Citation
Detaille D, Guigas B, Leverve X, Wiernsperger N, Devos P. Obligatory role of membrane events in the regulatory effect of metformin on the respiratory chain function. Biochem Pharmacol. 2002 Apr 1;63(7):1259-72. doi: 10.1016/s0006-2952(02)00858-4.
Results Reference
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PubMed Identifier
17941868
Citation
Tamura Y, Watada H, Sato F, Kumashiro N, Sakurai Y, Hirose T, Tanaka Y, Kawamori R. Effects of metformin on peripheral insulin sensitivity and intracellular lipid contents in muscle and liver of overweight Japanese subjects. Diabetes Obes Metab. 2008 Sep;10(9):733-8. doi: 10.1111/j.1463-1326.2007.00801.x. Epub 2007 Oct 15.
Results Reference
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PubMed Identifier
11756340
Citation
Standeven KF, Ariens RA, Whitaker P, Ashcroft AE, Weisel JW, Grant PJ. The effect of dimethylbiguanide on thrombin activity, FXIII activation, fibrin polymerization, and fibrin clot formation. Diabetes. 2002 Jan;51(1):189-97. doi: 10.2337/diabetes.51.1.189.
Results Reference
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PubMed Identifier
22974412
Citation
Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Ramos-Zavala MG, Barrera-Duran C, Gonzalez-Canudas J. Effect of metformin glycinate on glycated hemoglobin A1C concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2012 Dec;14(12):1140-4. doi: 10.1089/dia.2012.0097. Epub 2012 Sep 13.
Results Reference
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Citation
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)
Results Reference
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Citation
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
Results Reference
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Learn more about this trial

Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.

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