Phase 4 Osteoarthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to give written consent and follow all study procedures and schedules.
• People aged 40 years or older (male or female).
• Females who have a negative pregnancy test, are not breastfeeding, and do not plan to become pregnant from the screening period through the end of the study.
• People who have had Type 2 diabetes for at least 1 year before the screening visit.
• People currently taking injectable (non-insulin) and/or oral diabetes medications at a stable dose for at least 1 month before screening.
• People whose blood sugar control (HbA1c) is between 6.5% and 9%, measured within the past 8 weeks.
• People whose kidneys are functioning at an adequate level (eGFR of 50 or above), measured within the past 8 weeks.
• People whose triglyceride (blood fat) levels are below 500 mg/dL, measured within the past 8 weeks.
• People who have had painful knee osteoarthritis symptoms for at least 6 months before screening, with pain rated between 4 and 9 out of 10 on most days in the past month.
• People whose knee osteoarthritis meets specific established medical criteria, including knee pain, at least one of either joint stiffness lasting less than 30 minutes or a crackling/grating sensation in the knee, and bone spurs visible on imaging.
• People who have had pain in the affected knee on more than 15 days in the past month.
• People whose knee osteoarthritis is graded at a moderate severity level on X-ray (Kellgren-Lawrence Grade 2–4).
• People willing to wear a continuous glucose monitoring (CGM) device for 24 hours a day during required periods of the study and to perform blood sugar checks as directed.
• People who had sufficient blood sugar data collected during the pre-treatment phase (at least 70% of data available).

Who may not be able to join:

• People with other types of inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, or arthritis linked to inflammatory bowel disease.
• People with a history of infection in the affected knee joint.
• People who have shown signs of active knee infection or crystal-related joint disease in the affected knee within 1 month of screening.
• People who have surgical hardware or any other foreign object in the affected knee.
• People who have had an unstable knee joint (such as a torn ACL) within 12 months of screening.
• People with moderate or severe kidney, liver, or thyroid disease.
• People with glaucoma.
• People with currently active cancer.
• People who have received a steroid injection into any joint within 3 months of screening.
• People who have received a hyaluronic acid injection into the affected knee within 6 months of screening.
• People who have received steroid injections into a vein or muscle within 3 months of screening.
• People who have taken oral steroid medications within 1 month of screening.
• People who have used inhaled, nasal spray, or topical steroid treatments within 2 weeks of screening.
• People who have received any other investigational (experimental) injection into a joint within 6 months of screening, or within 5 half-lives of the substance — whichever is longer.
• People who have had arthroscopic or open surgery on the affected knee within 12 months of screening.
• People who have planned surgery on the affected knee or any other surgery during the study period.
• People who have used paracetamol (acetaminophen) or products containing it from the screening visit through Day 14 of the study.
• People taking blood-thinning medication (Coumadin/warfarin) with an INR level of 5 or higher.
• People with a known allergy or sensitivity to triamcinolone (the study drug or its components).
• People with a history of sarcoidosis or amyloidosis.
• People with an active cancer diagnosis or a history of cancer in the past 3 years, except for certain treated skin cancers or effectively managed cervical cancer (confirm with trial site).
• People with an active or dormant serious infection, including fungal, bacterial, tuberculosis, viral, or parasitic infections, or eye herpes simplex.
• People who have needed intravenous (IV) antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks of screening.
• People with a history of bone infection (osteomyelitis).
• People with known or suspected HIV, hepatitis B, or hepatitis C infection.
• People who are likely to need steroid treatment during the study period based on their medical history.
• People with a history of or currently active Cushing's syndrome or Addison's disease.
• People with active substance misuse (drugs or alcohol), or a history of ongoing substance misuse within the past year that the trial doctor considers likely to recur.
• People with broken or damaged skin at the knee where the injection would be given.
• People who have used immune-suppressing or chemotherapy medications within 2 years of screening.
• People who have received a live or live-attenuated vaccine within 3 months of screening.
• People with any other significant medical or psychiatric condition that, in the trial doctor's judgment, could affect safety, the ability to complete the study, or the reliability of study results.

Important: Always verify eligibility with the trial site directly before applying.