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NCT06478186 · ClinicalTrials.gov registry record · Phase 4
Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
A Phase 4 study of Diabetes Mellitus, Type 2 and Osteoarthritis, Knee, sponsored by University of Kansas Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06478186: Recruiting Phase 4 study of Diabetes Mellitus, Type 2 and Osteoarthritis, Knee, sponsored by University of Kansas Medical Center.
NCT06478186 is a Phase 4 study of Diabetes Mellitus, Type 2 and Osteoarthritis, Knee that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 120 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06478186, a Phase 4 study of Diabetes Mellitus, Type 2 and Osteoarthritis, Knee, is actively recruiting participants, sponsored by University of Kansas Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To assess continuous glucose monitoring (CGM) patterns for Time Above Range (TAR) levels of the upper limit of the recommended target range (glucose levels \>180 mg/dL) from Baseline to 72 hours following a single IA injection of 32 mg of ZILRETTA relative to 40 mg of TA-IR.
Conditions Studied
Interventions
- DRUG triamcinolone acetonide extended-release injectable suspension; TCA-ER
- DRUG Triamcinolone Acetonide- Immediate Release;TCA-IR
Study Locations (1)
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-08-16 |
| Est. Completion | 2026-10-16 |
| Phase | Phase 4 |
What NCT06478186 shows while recruiting
NCT06478186 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which triamcinolone acetonide extended-release injectable suspension; TCA-ER is the first listed.
NCT06478186 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT06478186 about?
NCT06478186 is a clinical study titled "Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes". 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) ...
What is the current status of trial NCT06478186?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2024-08-16. Estimated completion is 2026-10-16.
What conditions does trial NCT06478186 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Osteoarthritis, Knee.
What interventions are being tested in trial NCT06478186?
The interventions under investigation include: triamcinolone acetonide extended-release injectable suspension; TCA-ER (DRUG), Triamcinolone Acetonide- Immediate Release;TCA-IR (DRUG).
Who is sponsoring clinical trial NCT06478186?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06478186 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06478186's enrollment target sits among peer trials
120 188th of 348 higher than 157 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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