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Metformin hydrochloride plus drug combination to reduce pain, inflammation and biological aging in patients with knee osteoarthritis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on people with Osteoarthritis of the knee, a joint condition that causes pain and stiffness. The aim is to see whether combinations of already approved medicines can slow the increase in the body’s “cell‑age” signals, known as epigenetic and biological age acceleration. The medicines being tested are the HIV drug dolutegravir, the diabetes drug metformin hydrochloride, the gout medication colchicine, and the arthritis pill baricitinib. Each drug is taken by mouth in tablet form.

Participants will take the assigned drug pair for several months while continuing usual care. During the study they will have regular visits for blood and urine samples, simple pain questionnaires, and brief physical checks. The laboratory work will look at levels of inflammation‑related proteins and cytokines to understand any changes, and safety will be monitored by recording any unwanted effects or abnormal test results. The overall goal is to determine whether the drug combinations can reduce pain, lower inflammation, and affect the aging markers measured at the start and end of the trial.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    You are asked to join the study that investigates existing medicines for reducing aging, pain, and inflammation in osteoarthritis.

    You review information about the trial and sign a consent form indicating that you understand the purpose and agree to take part.

  2. Step 2

    Baseline assessments

    A series of initial measurements are performed before any medication is taken.

    Blood and urine samples are collected to evaluate epigenetic and biological age markers, inflammatory proteins, and other biomarkers.

    A questionnaire is completed to record current pain severity and any other symptoms related to knee osteoarthritis.

    The results provide a reference point for later comparisons.

  3. Step 3

    Receiving study medication

    You are provided with four oral tablets that will be taken as part of the study:

    tivicay 50 mg film-coated tablet containing dolutegravir, dose 50 mg.

    metformine hcl sandoz 500 mg film-coated tablet containing metformin hydrochloride, total daily dose 2000 mg.

    colchicine cf 0.5 mg tablet containing colchicine, dose 0.5 mg.

    olumiant 2 mg film-coated tablet containing baricitinib, dose 2 mg.

  4. Step 4

    Starting medication regimen

    You begin taking the study tablets by mouth according to the schedule given by the study team.

    The exact frequency (for example, once daily) and the total length of time you will take each medication are explained during the visit.

    You are reminded to follow the dosing instructions precisely and not to change the schedule without consulting the study staff.

  5. Step 5

    Regular follow‑up visits

    Periodic visits are scheduled throughout the trial to monitor progress.

    During each visit blood and urine samples are taken again to assess changes in epigenetic age, inflammatory proteins, and other biomarkers.

    Pain severity is re‑evaluated using the same questionnaire as at baseline.

    The study staff checks that the medication is being taken as directed and reviews any symptoms you may have experienced.

  6. Step 6

    Safety monitoring

    At each visit laboratory tests are performed to detect any abnormal results that could indicate a problem.

    You are asked to report any side effects or health changes, which are recorded as adverse events.

    The study team evaluates the safety of the drug combinations based on these reports and test results.

  7. Step 7

    Final assessments

    At the end of the study period a comprehensive assessment is performed.

    Blood and urine are collected a final time to compare with the baseline results.

    Pain severity and other clinical measurements are repeated.

    The overall change in the primary and secondary outcomes is documented.

  8. Step 8

    Study completion

    After the final visit you stop taking the study medication as instructed.

    The study team provides a summary of your participation and any relevant findings.

    Your involvement in the trial concludes.

Who can join the trial?

4 criteria

  • You must sign a written informed consent form, showing you agree to join the study.
  • You need to be at least 18 years old but younger than 80.
  • You must have a doctor’s diagnosis of knee osteoarthritis confirmed by an X‑ray (a radiological diagnosis) and the X‑ray must show a severity of at least Kellgren‑Lawrence (KL) grade 2, which means moderate joint damage.
  • You must be able to swallow and keep a pill in your mouth, meaning you can take oral medication.

Who cannot join the trial?

30 criteria

  • If you are allergic or have a strong reaction to any of the study drugs (baricitinib, dolutegravir, metformin, colchicine) or any of their ingredients, you cannot take part.
  • If you received any vaccination in the two weeks before the study starts, you are not eligible.
  • If you have nerve inflammation (peripheral neuritis), muscle inflammation (myositis), or severe muscle problems caused by cholesterol medicines (statins), you cannot join.
  • Male participants who are not willing to use reliable birth control during the study are excluded.
  • If you are taking medicines that interfere with how the body processes other drugs (such as many antibiotics, antifungal medicines, anti‑viral drugs, anti‑seizure medicines, certain heart medicines, or herbal products like St. John’s wort), you cannot participate.
  • If you have any other medical condition that affects your joints, you are excluded.
  • If you have a generalized pain condition such as fibromyalgia, you cannot join.
  • If you are very frail (a score of 7 or higher on a standard frailty scale) or doctors expect you may live less than five years, you are not eligible.
  • If you are already enrolled in another clinical trial, you cannot take part.
  • If you are unable to understand the study or give consent (incapacitated), you are excluded.
  • If you are pregnant or are breastfeeding, you cannot join.
  • If you have a planned surgery that requires general, spinal, or epidural anesthesia, you are not eligible.
  • If you are a fertile woman and are not using effective contraception, you cannot participate.
  • If you have been diagnosed with depression, you are excluded.
  • If you have a weakened immune system (immunodeficiency) or an autoimmune disease (where the body attacks itself), you cannot join.
  • If you have acute or unstable heart failure (the heart cannot pump blood well), you are not eligible.
  • If you have an alcohol addiction (more than 14 drinks per week), you cannot participate.
  • If you currently smoke or have a long‑term history of smoking at least one cigarette per day, you are excluded.
  • If you have ever had hepatitis B or tuberculosis, you cannot join.
  • If you have ever had cancer, you are not eligible.
  • If you are scheduled for an imaging test that uses iodine dye injected into your blood vessels, you cannot take part.
  • If you have had shingles (herpes zoster), you are excluded.
  • If you have any acute metabolic acidosis (dangerously high blood acidity, such as lactic acidosis or diabetic ketoacidosis), you cannot join.
  • If you have had a blood clot in a vein (venous thromboembolism), you are not eligible.
  • If you are already taking any of the study drugs (baricitinib, dolutegravir, metformin, colchicine) for any reason, you cannot participate.
  • If your kidney function is moderately or severely reduced (eGFR less than 50 mL/min/1.73 m²), you are excluded.
  • If your liver enzymes are more than three times the normal limit (high alanine transferase), you cannot join.
  • If you have low blood cell counts (very low lymphocytes, neutrophils, or hemoglobin), you are not eligible.
  • If you are using systemic immunomodulatory drugs such as steroids or special anti‑inflammatory biologic medicines, you cannot participate.
  • If you have had an acute or active illness within two weeks before the study starts, you are excluded.
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Investigated drugs

  • Dolutegravir

    is a medicine originally used to treat HIV infection. In this study it is being tested to see if it can help slow down the biological processes that make cells age faster, which might improve joint health in people with knee osteoarthritis.

  • Metformin

    is a common medication for type 2 diabetes. Researchers are exploring whether it can also reduce the speed of biological aging and lower inflammation, which could lessen pain and damage in osteoarthritic knees.

  • Colchicine

    is a drug that is often used to treat gout attacks because it reduces inflammation. In this trial it is being evaluated for its ability to lower joint inflammation and pain in osteoarthritis, and possibly help slow age‑related changes in the knee.

  • Baricitinib

    is a medication that blocks certain immune signals and is used for rheumatoid arthritis. The study is checking if it can decrease inflammation and slow the aging of joint tissues, which may improve symptoms for people with knee osteoarthritis.

What is already known about the treatment

  • Dolutegravir

    Dolutegravir is taken as a 50 mg film‑coated tablet taken by mouth. It is an approved antiretroviral drug widely used to treat HIV infection and is well documented in medical literature. It works by blocking the HIV integrase enzyme, preventing the virus from inserting its genetic material into human cells. Pharmacologically it is classified as an integrase strand transfer inhibitor.

  • Metformin

    Metformin is supplied as 500 mg film‑coated tablets taken orally, usually in divided doses up to a total of 2000 mg per day. It is a first‑line, approved treatment for type 2 diabetes and has a long history of use in clinical practice. Its action comes from activating an enzyme called AMPK, which helps lower blood sugar by reducing liver glucose production and improving insulin sensitivity. It belongs to the biguanide class of oral hypoglycemic agents.

  • Colchicine

    Colchicine is provided as 0.5 mg tablets taken by mouth. It is an approved medication for acute gout attacks and for preventing flare‑ups of familial Mediterranean fever. The drug binds to tubulin, a protein inside cells, and stops the formation of microtubules, which reduces inflammation caused by white‑blood‑cell activity. It is classified as an alkaloid anti‑inflammatory agent.

  • Baricitinib

    Baricitinib comes as a 2 mg film‑coated tablet taken orally once daily. It is approved for rheumatoid arthritis and has also received emergency use approval for certain COVID‑19 patients. It works by inhibiting Janus kinase (JAK) enzymes, which dampens the signaling that leads to inflammation. Pharmacologically it is a Janus kinase (JAK) inhibitor.

Investigated diseases

Osteoarthritis - Osteoarthritis is a joint condition in which the smooth cartilage that cushions bone ends gradually wears away. As the cartilage thins, the joint can become stiff and painful, especially after use. Small bone fragments and bone spurs may develop, further limiting movement. The condition typically progresses slowly, with symptoms becoming more frequent and noticeable over time. Eventually, the joint may show increased swelling and reduced flexibility.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524885-12-00Protocol codeR0128381AEstimated enrolment175 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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