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Zilretta vs Kenalog on Blood Glucose in Knee Osteoarthritis and Type 2 Diabetes
NCT06478186Phase 4
Key facts
- Status
- Recruiting
- Start
- Aug 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University of Kansas Medical Center
- Modality
- Orthosteric Ligands
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 4, randomised, double-blind trial of triamcinolone acetonide in osteoarthritis (OA) (2 arms), sponsored by University of Kansas Medical Center. Primary endpoint: Percent of time spent with blood glucose >180 mg/dL at 72 hours. Started Aug 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
TA-ER
Zilretta (triamcinolone acetonide extended-release) 32 mg intra-articular injection
TA-IR
Kenalog (triamcinolone acetonide immediate-release) 40 mg intra-articular injection
03
Who it enrols
Patients >=40 years with symptomatic knee osteoarthritis and type 2 diabetes mellitus (HbA1c 6.5-9%) managed without insulin.
04
Endpoints
Primary
Percent of time spent with blood glucose >180 mg/dL
Secondary
Area under the curve (AUC) for cortisol levels
Percentage of time spent with blood glucose above >180 mg/dL
Number of blood glucose peaks >=250 mg/dL
Change in 40m walk time
Change in stair climb time
Change in patient-reported physical function (KOOS-PS)
Change in quality of life (KOOS-QoL)
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