RecruitingPhase 4NCT06478186

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

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

Sponsor

University of Kansas Medical Center

Enrollment

120 participants

Start Date

Aug 16, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Osteoarthritis, Knee

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.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study compares two steroid injections for painful knee osteoarthritis in patients with Type 2 diabetes: Zilretta (a slow-release formulation designed to minimise blood sugar spikes) versus Kenalog (a standard corticosteroid injection). Steroid injections can raise blood sugar, which is especially risky for people with diabetes. **You may be eligible if...** - You are 40 or older with Type 2 diabetes (diagnosed at least 1 year ago) - You have painful knee osteoarthritis - Your blood sugar (HbA1c) is between 6.5–9% - You are on stable diabetes medication for at least 1 month **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your kidney function is significantly impaired (eGFR below 50) - Your triglyceride levels are very high (above 500 mg/dL) - You have had a recent steroid injection in the same knee Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtriamcinolone 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

DRUGTriamcinolone 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

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NCT06478186

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