Severe Acute Respiratory Syndrome Coronavirus 2Phase 2DMMETCOV19-2NCT04625985
Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.
A Phase 2 study testing Metformin Glycinate in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Metformin Glycinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 14 Jul 2020to 18 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
The American British Cowdray Medical Center, I.A.P
Mexico City, 01120
About this study
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
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.
Read the 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.
- Being tested
- Metformin Glycinate, Placebo oral tablet
- Keywords
- SARS-COV 2, Severe acute respiratory syndrome
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin GlycinateDrug
Also called DMMET
Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment
Placebo oral tabletDrug
Also called Placebo
Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Metformin glycinate | Experimental | 620 mg bid (PO) for 14 days plus standard treatment Receives: Drug: Metformin Glycinate |
| Placebo | Placebo comparator | Placebo tablet bid (PO) for 14 days plus standard treatment Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Measured: Day 0 to Day 28 or patient discharge day
consciousness level
Clinical status assessed by measurement of consciousness level: alertness
Measured: Day 0 to Day 28 or patient discharge day
temperature
Clinical status assessed by measurement of axillary body temperature in °C: <37.2.
Measured: Day 0 to Day 28 or patient discharge day
systolic blood pressure
Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.
Measured: Day 0 to Day 28 or patient discharge day
Oxigen saturation
Clinical status assessed by measurement of oxygen saturation in %: >90.
Measured: Day 0 to Day 28 or patient discharge day
Heart rate
Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm.
Measured: Day 0 to Day 28 or patient discharge day
respiratory rate
Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm,
Measured: Day 0 to Day 28 or patient discharge day
Days of hospitalization
Assess length of hospitalization
Measured: Day 0 to Day 28 or patient discharge day
Days of supplementary oxygen if applies
Assess length of supplementary oxygen
Measured: Day 0 to Day 28 or patient discharge day
Days of supplementary mechanical ventilation
Assess length of mechanical ventilation
Measured: Day 0 to Day 28 or patient discharge day
Secondary outcomes (2)
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)
Measured: Day 0 to Day 28 or patient discharge day
Changes in laboratory test results
Changes in serum levels from security laboratories compared to baseline levels and between groups.
Measured: Day 0 to Day 28 or patient discharge day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start14 Jul 2020
- Primary completion8 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Silvia M Aguirre, MD, Principal investigator, The American British Cowdray Medical Center. I.A.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625985
- Sponsor's protocol ID
- SIL-30000-II-20(2)
- Acronym
- DMMETCOV19-2
- Status last verified
- Apr 2021
- First submitted
- 23 Oct 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20380657Cuthbertson 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.
PubMed 19538242Musi 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.
PubMed 12086935Shaw 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.
PubMed 16308421Detaille 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.
PubMed 11960602Tamura 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.
PubMed 17941868Standeven 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.
PubMed 11756340Gonzalez-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.
PubMed 22974412Jorge 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04625985
- Acronym / sponsor ID
- DMMETCOV19-2 / SIL-30000-II-20(2)
- Keywords
- SARS-COV 2, Severe acute respiratory syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Metformin glycinate | Experimental | Drug: Metformin Glycinate620 mg bid (PO) for 14 days plus standard treatment |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo tablet bid (PO) for 14 days plus standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin GlycinateAlso: DMMETParticipants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment | Drug | Metformin glycinate |
| Placebo oral tabletAlso: PlaceboParticipants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment | Drug | Placebo |
Primary outcome
Viral load
Time frame: Day 0 to Day 28 or patient discharge day
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
consciousness level
Time frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of consciousness level: alertness
temperature
Time frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of axillary body temperature in °C: <37.2.
systolic blood pressure
Time frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.
Oxigen saturation
Time frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of oxygen saturation in %: >90.
Heart rate
Time frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm.
respiratory rate
Time frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm,
Days of hospitalization
Time frame: Day 0 to Day 28 or patient discharge day
Assess length of hospitalization
Days of supplementary oxygen if applies
Time frame: Day 0 to Day 28 or patient discharge day
Assess length of supplementary oxygen
Days of supplementary mechanical ventilation
Time frame: Day 0 to Day 28 or patient discharge day
Assess length of mechanical ventilation
2 secondary outcomes
Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4)
Time frame: Day 0 to Day 28 or patient discharge day
Changes in laboratory test results
Time frame: Day 0 to Day 28 or patient discharge day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 20380657Fischer 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.
- Background: PubMed 19538242Cuthbertson 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 publication: PubMed 12086935Musi 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 publication: PubMed 16308421Shaw 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 publication: PubMed 11960602Detaille 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 publication: PubMed 17941868Tamura 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 publication: PubMed 11756340Standeven 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 publication: PubMed 22974412Gonzalez-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 publicationJorge 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 publicationGarza-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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Silvia M Aguirre, MD principal investigator
The American British Cowdray Medical Center. I.A.P.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin Glycinate in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load (time frame: Day 0 to Day 28 or patient discharge day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625985, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.