Knee OsteoarthritisPhase 2/3NCT05638893
Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
A Phase 2/3 study testing Metformin Hcl 500Mg Tab in people with Knee Osteoarthritis, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Metformin Hcl 500Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 15 Apr 2022
- Phase
- Phase 2/3
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have symptomatic and radiological evidence of OA in one or both knee joints.
- Age ≥ 45 years.
- Both obese male and female will be included (BMI ≥ 30 kg/m²).
Who cannot join
- Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA.
- Patient with hypertension or diabetes mellitus.
- Patient with hepatic or renal impairment.
- Patients who have active peptic ulcer.
- Patients with positive malignancy.
- Steroid injection into the affected knee joint within 3 months of recruitment for the study.
- Pregnant or lactating female patients.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
Read the detailed description
Metformin is a safe, well-tolerated oral biguanide widely used as first-line therapy for type 2 diabetes for over 50 years. In addition to its glucose-lowering effects, metformin modulates inflammatory and metabolic factors resulting in weight loss and reduced inflammation and plasma lipids. Data from animal studies suggest that metformin could limit OA development and progression, possibly through activating AMPK.
Retrospective cohort study of participants with OA and type 2 diabetes reported that patients receiving a combination of cyclooxygenase-2 inhibitors and metformin therapy had a lower risk of joint replacement than those receiving cyclooxygenase-2 inhibitors alone .
These findings shed light on possible therapeutic potential of metformin in treatment of OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Placebo Tablet, Metformin Hcl 500Mg Tab
- Keywords
- Metformin, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo TabletDrug
Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.
Metformin Hcl 500Mg TabDrug
Also called Cidophage 500mg Oral Tablet
Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Experimental | Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks. Receives: Drug: Placebo Tablet |
| Metformin group | Experimental | Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks. Receives: Drug: Metformin Hcl 500Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.
Measured: 12 weeks
Weight (Kg)
Measure change in weight in kilograms at baseline and after 12weeks of treatment.
Measured: 12 weeks
Secondary outcomes (4)
Cartilage Oligomeric Matrix Protein (COMP)
Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment.
Measured: 12 weeks
C-terminal crosslinked telopeptide of type I collagen (CTX-1)
Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment.
Measured: 12 weeks
Interleukin 1-beta (IL-1β)
Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment.
Measured: 12 weeks
Adverse drug events
side effects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Feb 2021
- Primary completion12 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Abd Elaal Mohamed Aiad, Tanta University
- Investigators
- Sahar M El-Haggar, Professor, Study chair, Tanta UniversityAmal M El-Barbary, Professor, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638893
- Sponsor's protocol ID
- Metformin knee osteoarthritis
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aiad AAE, El-Haggar SM, El-Barbary AM, El-Afify DR. Metformin as adjuvant therapy in obese knee osteoarthritis patients. Inflammopharmacology. 2024 Aug;32(4):2349-2359. doi: 10.1007/s10787-024-01495-y. Epub 2024 Jun 13.
PubMed 38869746
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT05638893
- Acronym / sponsor ID
- Metformin knee osteoarthritis
- Conditions
- Knee Osteoarthritis
- Keywords
- Metformin, knee osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 6 Dec 2022 (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.
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
Detailed description
Metformin is a safe, well-tolerated oral biguanide widely used as first-line therapy for type 2 diabetes for over 50 years. In addition to its glucose-lowering effects, metformin modulates inflammatory and metabolic factors resulting in weight loss and reduced inflammation and plasma lipids. Data from animal studies suggest that metformin could limit OA development and progression, possibly through activating AMPK.
Retrospective cohort study of participants with OA and type 2 diabetes reported that patients receiving a combination of cyclooxygenase-2 inhibitors and metformin therapy had a lower risk of joint replacement than those receiving cyclooxygenase-2 inhibitors alone .
These findings shed light on possible therapeutic potential of metformin in treatment of OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Experimental | Drug: Placebo TabletPlacebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks. |
| Metformin group | Experimental | Drug: Metformin Hcl 500Mg TabMetformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients have symptomatic and radiological evidence of OA in one or both knee joints.
- Age ≥ 45 years.
- Both obese male and female will be included (BMI ≥ 30 kg/m²).
Key exclusion criteria (7 listed)
- Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA.
- Patient with hypertension or diabetes mellitus.
- Patient with hepatic or renal impairment.
- Patients who have active peptic ulcer.
- Patients with positive malignancy.
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 |
|---|---|---|
| Placebo TabletPlacebo (tablet/12hr) + celecoxib (200mg/day) for three months. | Drug | Placebo group |
| Metformin Hcl 500Mg TabAlso: Cidophage 500mg Oral TabletMetformin (500mg/12hr) + celecoxib (200mg/day) for three months. | Drug | Metformin group |
Primary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 12 weeks
Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.
Weight (Kg)
Time frame: 12 weeks
Measure change in weight in kilograms at baseline and after 12weeks of treatment.
4 secondary outcomes
Cartilage Oligomeric Matrix Protein (COMP)
Time frame: 12 weeks
C-terminal crosslinked telopeptide of type I collagen (CTX-1)
Time frame: 12 weeks
Interleukin 1-beta (IL-1β)
Time frame: 12 weeks
Adverse drug events
Time frame: 12 weeks
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 7 Dec 2022.
- Derived from this study: PubMed 38869746Aiad AAE, El-Haggar SM, El-Barbary AM, El-Afify DR. Metformin as adjuvant therapy in obese knee osteoarthritis patients. Inflammopharmacology. 2024 Aug;32(4):2349-2359. doi: 10.1007/s10787-024-01495-y. Epub 2024 Jun 13.
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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.
Sahar M El-Haggar, Professor study chair
Tanta University
Amal M El-Barbary, Professor study chair
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin Hcl 500Mg Tab in people with Knee Osteoarthritis, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 7 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 7 Dec 2022. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: 12 weeks). The study lists 2 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 NCT05638893, which also lists 1 linked publication.
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 7 Dec 2022.