Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
Eligible age
40+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR; Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis. Subjects should have Type 2 Diabetes Mellitus (T2DM) with HbA1C ≤9 that is managed without insulin and have been diagnosed with symptomatic unilateral or bilateral osteoarthritis (OA) of the knee, based on clinical and radiological criteria (if bilateral, then a target knee will be selected).Total study duration for individual subject will be about 4 months, which includes 3 weeks of Screening period, 10 days of pretreatment phase, treatment day, and 12 weeks of post-treatment period.
Sponsor: University of Kansas Medical Center
You may qualify if…
- ✓ 1\. Written consent to participate in the study. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
- ✓ 3\. Male or female ≥40 years of age. 4. Females with negative pregnancy test, who are not breastfeeding and have no intention to become pregnant during the time from screening through EOS.
- ✓ 5\. Type 2 DM for at least 1 year prior to Screening. 6. Currently being treated with injectable (except insulin) and/or oral antidiabetic agents with stable doses for at least 1 month prior to Screening.
- ✓ 7\. HbA1c 6.5-9% (in past 8 weeks). 8. Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2. (in past 8 weeks) 9. Triglycerides \<500 mg/dL (in past 8 weeks) 10. Painful symptoms associated with OA of the knee for ≥6 months prior to Screening (NRS of 4-9 during most of the 30 days prior to enrollment).
- ✓ 11\. Currently meets modified ACR criteria (clinical and radiological) for OA (Altman et al, 1986) as follows:
- ✓ 1. Knee pain
- ✓ 2. At least 1 of the following:
- ✓ Stiffness \<30 minutes
You may not qualify if…
- ✕ Disease-related Criteria
- ✕ 1. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
- ✕ 2. History of infection in the index knee joint.
- ✕ 3. Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening.
- ✕ 4. Presence of surgical hardware or other foreign body in the index knee.
- ✕ 5. Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening.
- ✕ 6. Moderate or severe kidney, liver, or thyroid disease.
- ✕ 7. Glaucoma.
Where it's recruiting
Kansas City
Source: ClinicalTrials.gov · NCT06478186 · last updated 2026-05-28