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RECRUITING
NCT06478186
PHASE4

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

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

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.

Official title: RCT to Evaluate the Effects of Zilretta (Triamcinolone Acetonide- Extended Release) and Kenalog (Triamcinolone Acetonide- Immediate Release) on Blood Glucose in Subjects With Osteoarthritis of the Knee and Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-08-16

Completion Date

2026-10-16

Last Updated

2025-07-09

Healthy Volunteers

No

Interventions

DRUG

triamcinolone acetonide extended-release injectable suspension; TCA-ER

Mode of Administration: IA Knee Injection Nominal 32 mg TCA, intra-articular (IA) injection, administered as a 5 mL injection

DRUG

Triamcinolone Acetonide- Immediate Release;TCA-IR

Mode of Administration: IA Knee Injection Triamcinolone Acetonide- Immediate Release (TCA-IR)

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States