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NCT03772964

Effects of Metformin in a Non-Diabetic Patient Population

Completed Phase 1, PHASE2 Results posted Last updated 11 January 2023
What this trial tests

Phase 1, PHASE2 trial testing MetFORMIN Hydrochloride ER in Inflammatory Response in 32 participants. Completed in 31 March 2020.

Timeline
22 January 2019
Primary endpoint
31 March 2020
31 March 2020

Quick facts

Lead sponsorBrian Zuckerbraun
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposebasic science
Enrollment32
Start date22 January 2019
Primary completion31 March 2020
Estimated completion31 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brian Zuckerbraun

Who can join

Adults 55 to 85, any sex, with Inflammatory Response. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quantify the Bacterial Population Profile of the Microbiome Via Stool Samples. Secondary · Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)

Bacterial communities using 16S rRNA sequencing in relationship to metformin dosing over time. Species richness or diversity in the sample is measured by Choa1 metric. Chao1 is an estimate of how many species are present in an ecosystem. In general, having more species is considered to be "healthier" and these values typically range from 100-200 for fecal samples. The Chao1 index over numerous samples across time are explored to understand treatment effects.

Day 0
GroupValue95% CI
500mg Exposure136.5± 19.0
1000mg Exposure107.6± 13.3
1500mg Exposure128.1± 10.5
Placebo141.5± 15
Day 30
GroupValue95% CI
500mg Exposure139.9± 16.2
1000mg Exposure130.7± 19.4
1500mg Exposure128.1± 13.2
Placebo144.75± 13.2
Day 60
GroupValue95% CI
500mg Exposure121.4± 20.8
1000mg Exposure137.9± 17.7
1500mg Exposure128.6± 12.7
Placebo134.3± 9.8
Day 90
GroupValue95% CI
500mg Exposure137.8± 27.8
1000mg Exposure135± 18.9
1500mg Exposure138.2± 10.3
Placebo152± 20.5
Day 120
GroupValue95% CI
500mg Exposure134± 23.6
1000mg Exposure142.2± 17.3
1500mg Exposure144.2± 16.5
Placebo159.2± 5.7
Measure the Rate of Clotting of Peripheral Blood With Whole Blood Aggregometry in Response to Collagen. Secondary · Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)

Aggregometry area under the curve with the Y-axis being % aggregometry and the X-axis time in minutes.

0 days
GroupValue95% CI
500mg Exposure56.3± 40
1000mg Exposure67± 38
1500mg Exposure196± 376
Placebo83.3± 69
30 day change from day 0
GroupValue95% CI
500mg Exposure-34.7± 24.5
1000mg Exposure8.9± 50.1
1500mg Exposure-166.7± 409
Placebo-29.6± 104.8
60 days change from day 0
GroupValue95% CI
500mg Exposure-28.3± 54
1000mg Exposure-23.5± 44.5
1500mg Exposure-139.8± 376.3
Placebo-49.4± 86.7
90 days change from day 0
GroupValue95% CI
500mg Exposure1.6± 57.6
1000mg Exposure2.4± 84.5
1500mg Exposure-222.5± 456.2
Placebo-66.6± 102.6
120 days change from day 0
GroupValue95% CI
500mg Exposure-49.2± 84.2
1000mg Exposure1.0± 28.9
1500mg Exposure-196.7± 410.6
Placebo-47.6± 103.0
Changes From Baseline in Short Physical Performance Battery (SPPB) During and Following Exposure to Metformin. Secondary · Day 0 (baseline), 90, and 120 (30 days post metformin exposure)

The SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The minimum is zero (worse performance) and the maximum is 12 (best performance).

0d
GroupValue95% CI
500mg Exposure11.2± .9
1000mg Exposure10.8± 1.3
1500mg Exposure11.1± 0.9
Placebo10.6± 1.3
90d, change from 0d
GroupValue95% CI
500mg Exposure-0.3± 1.4
1000mg Exposure0.4± 0.7
1500mg Exposure0.4± 0.5
Placebo1.0± 1.0
120d, change from 0d
GroupValue95% CI
500mg Exposure0± 0.6
1000mg Exposure0.2± 1.0
1500mg Exposure0.3± 1.3
Placebo0.5± .8
Changes From Baseline in Grip Strength Via a Dynamometer During and Following Exposure to Metformin. Secondary · Day 0 (baseline), 90, and 120 (30 days post metformin exposure)

Grip strength over time.

0 days
GroupValue95% CI
500mg Exposure28.2± 10.3
1000mg Exposure28.9± 8.3
1500mg Exposure25.7± 7.8
Placebo25.7± 9.2
90 days, compared to 0 days
GroupValue95% CI
500mg Exposure-5.3± 12.5
1000mg Exposure-0.4± 3.1
1500mg Exposure-.2± 2.1
Placebo-.3± 3.5
120 days, compared to 0 days
GroupValue95% CI
500mg Exposure.1± 4.8
1000mg Exposure1.1± 2.7
1500mg Exposure.3± 3.0
Placebo-.6± 2.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored from the time of randomization for 120 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

500mg Exposure
Serious: 0/8 (0%)
Deaths: 0/8
1000mg Exposure
Serious: 0/8 (0%)
Deaths: 0/8
1500mg Exposure
Serious: 0/8 (0%)
Deaths: 0/8
Placebo
Serious: 0/8 (0%)
Deaths: 0/8
Other adverse events (3 terms — click to expand)

ReactionSystem500mg Exposure1000mg Exposure1500mg ExposurePlacebo
Gastrointestinal symptomsGastrointestinal disorders————
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders————
Joint pain or fractureMusculoskeletal and connective tissue disorders————

Data from ClinicalTrials.gov NCT03772964 adverse events section.

Sponsor's own description

Metformin has a well-established safety profile and it has become clear that metformin has additional salutary effects, including anti-inflammatory, anti-aging, and anti-thrombotic properties. In this study, subjects will provide both venous blood samples and stool samples in addition to completing cognitive and physiologic testing at baseline, throughout a 90 day exposure to metformin, and 30 days following exposure to metformin in order to evaluate their immune, microbiome, cellular respiration, thrombotic, and inflammatory responses.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inflammation and atherosclerosis: signaling pathways and therapeutic intervention.
    Kong P, Cui ZY, Huang XF, Zhang DD, et al · · 2022 · cited 749× · PMID 35459215 · DOI 10.1038/s41392-022-00955-7
  2. Phenformin as an Anticancer Agent: Challenges and Prospects.
    García Rubiño ME, Carrillo E, Ruiz Alcalá G, Domínguez-Martín A, et al · · 2019 · cited 73× · PMID 31284513 · DOI 10.3390/ijms20133316
  3. Metformin as Potential Therapy for High-Grade Glioma.
    Mazurek M, Litak J, Kamieniak P, Kulesza B, et al · · 2020 · cited 69× · PMID 31952173 · DOI 10.3390/cancers12010210
  4. Drugs Targeting Mechanisms of Aging to Delay Age-Related Disease and Promote Healthspan: Proceedings of a National Institute on Aging Workshop.
    Espinoza SE, Khosla S, Baur JA, de Cabo R, et al · · 2023 · cited 19× · PMID 37325957 · DOI 10.1093/gerona/glad034
  5. Effect of Cellular Senescence in Disease Progression and Transplantation: Immune Cells and Solid Organs.
    Kirchner VA, Badshah JS, Hong SK, Martinez O, et al · · 2024 · cited 8× · PMID 37953486 · DOI 10.1097/tp.0000000000004838

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Other recruiting trials for Inflammatory Response

Currently open trials in the same condition.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03772964.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing