Actively Recruiting
Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
Led by University of Kansas Medical Center · Updated on 2025-07-09
120
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written consent to participate and agree to follow study procedures and visits
- Male or female aged 40 years or older
- Females must have a negative pregnancy test, not be breastfeeding, and agree to avoid pregnancy during the study
- Have type 2 diabetes mellitus for at least 1 year prior to screening
- Currently on stable doses of injectable (non-insulin) and/or oral antidiabetic medications for at least 1 month prior to screening
- Have HbA1c between 6.5% and 9% in the past 8 weeks
- Have estimated glomerular filtration rate (eGFR) of 50 mL/min/1.73 m2 or higher in the past 8 weeks
- Have triglycerides less than 500 mg/dL in the past 8 weeks
- Experience knee osteoarthritis pain for at least 6 months prior to screening with pain rated 4 to 9 on numeric scale most days in the last 30 days
- Meet modified American College of Rheumatology criteria for osteoarthritis with knee pain, stiffness less than 30 minutes or crepitus, and presence of osteophytes
- Have index knee pain more than 15 days in the last month
- Kellgren-Lawrence grade 2 to 4 for knee osteoarthritis
- Willingness to wear a continuous glucose monitor device continuously during the study and comply with its correct use
- Have at least 70% adequate blood glucose data collected during the pretreatment phase (Day -10 to Day -1)
You will not qualify if you...
- Diagnosed with reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in the index knee joint
- Signs or symptoms of active knee infection or crystal disease within 1 month before screening
- Presence of surgical hardware or foreign body in the index knee
- Unstable knee joint, such as torn anterior cruciate ligament within 12 months before screening
- Moderate or severe kidney, liver, or thyroid disease
- Glaucoma
- Active cancer
- Received intra-articular corticosteroids in any joint within 3 months before screening
- Received intra-articular hyaluronic acid in the index knee within 6 months before screening
- Received intravenous or intramuscular corticosteroids within 3 months before screening
- Received oral corticosteroids within 1 month before screening
- Received inhaled, intranasal, or topical corticosteroids within 2 weeks before screening
- Received any other intra-articular investigational drug or device within 6 months before screening
- Had arthroscopic or open surgery of the index knee within 12 months before screening
- Planned or anticipated knee or other surgery during the study
- Use of acetaminophen or acetaminophen-containing products from screening through Day 14
- On Coumadin with INR of 5 or higher
- Known allergy to any form of triamcinolone
- History of sarcoidosis or amyloidosis
- Active or recent malignancy within 3 years except certain skin or cervical cancers
- Known or suspected active or past infections including fungal, bacterial, viral, or parasitic
- Infection requiring IV antibiotics within 4 weeks or oral antibiotics within 2 weeks before screening
- History of osteomyelitis
- Known or suspected infection with HIV or hepatitis B or C
- Need or likely need corticosteroid treatment during the study
- History or active Cushing's or Addison's syndrome
- Active or recent substance abuse within the last year
- Skin breakdown at the knee injection site
- Use of immunomodulators, immunosuppressives, or chemotherapy within 2 years before screening
- Received live or live attenuated vaccine within 3 months before screening
- Any other significant psychiatric or medical condition that could affect safety or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
J
Jeannine Nilges, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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