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Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 16, 2026 to Dec 16, 2026 Completion date: Oct 16, 2026 to Jan 16, 2027 · Site contact updatedv4 Show 2 more changesShow less
    • Completion date: Oct 16, 2026 to Jan 16, 2027
    • Site contact updated
  2. Completion date: Jul 16, 2026 to Oct 16, 2026 Site contact updatedv3 Show 1 more changeShow less
    • Site contact updated
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 16, 2024 to Aug 16, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 16, 2024 to Aug 16, 2024
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06478186
Lead Sponsor University of Kansas Medical Center
Conditions Osteoarthritis, Knee, Diabetes Mellitus, Type 2
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov