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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06478186
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • triamcinolone acetonide extended-release injectable suspension; TCA-ER — DRUG
    Mode of Administration: IA Knee Injection Nominal 32 mg TCA, intra-articular (IA) injection, administered as a 5 mL injection
  • Triamcinolone Acetonide- Immediate Release;TCA-IR — DRUG
    Mode of Administration: IA Knee Injection Triamcinolone Acetonide- Immediate Release (TCA-IR)

Study Details

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.

Key Dates

Start date
Aug 16, 2024
Status verified
May 2026
Primary completion
Dec 16, 2026
Completion
Jan 16, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TA-ER
    Name: ZILRETTA (triamcinolone acetonide extended-release injectable suspension; TA-ER) Active ingredient: Extended-release formulation of TA in 75:25 poly (lactic-co-glycolic) acid (PLGA) microspheres Dosage: Nominal 32 mg TA, intra-articular (IA) injection, administered as a 5 mL injection Mode of Administration: IA Knee Injection
  • Active Comparator: TA-IR
    Name: Kenalog®-40 (triamcinolone acetonide injectable suspension) Active Ingredient: Triamcinolone Acetonide- Immediate Release (TA-IR) Dosage: 40 mg/mL, IA, administered as a 1 mL Injection: TA-IR Mode of Administration: IA Knee Injection

Primary Outcome Measure

Percent of time spent with blood glucose >180 mg/dL [ Time Frame: The primary outcome will be measured up to 72 hours after treatment by a sensor automatically uploading the data ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Neil Segal, MD, MS
[email protected]
9135886944
Jessica Lee, PhD
9135740961
Neil Segal, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Kansas City, KS

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Kansas Medical Center· Kansas City, KS

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