Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
NCT Number: NCT06478186
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Osteoarthritis, Knee|Diabetes Mellitus, Type 2
Interventions: DRUG: triamcinolone acetonide extended-release injectable suspension; TCA-ER|DRUG: Triamcinolone Acetonide- Immediate Release;TCA-IR
Sponsor: University of Kansas Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2026-07-16
Locations: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States

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 Measures: Percent of time spent with blood glucose >180 mg/dL, 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., The primary outcome will be measured up to 72 hours after treatment by a sensor automatically uploading the data
Secondary Outcome Measures: Area under the curve (AUC) for cortisol levels, To characterize HPA axis suppression from Baseline until the end-of-study comparing ZILRETTA vs TA IR., From baseline until the end-of-study (Day 85).|Percentage of time spent with blood glucose above >180 mg/dL, To characterize the number of subjects and percentage of time spent in TAR from Baseline throughout the10 days comparing ZILRETTA vs TA-IR., From baseline throughout 10 days follow-up.|Number of blood glucose peaks ≥250 mg/dL, To characterize number of peaks ≥250 mg/dL per subject from Baseline throughout the 10 days comparing ZILRETTA vs TCA-IR., From baseline throughout 10 days follow-up|Change in 40m walk time, To determine the extent to which intra-articular (IA) injection of Zilretta vs. TA-IR in patients with dual diagnosis of T2DM and knee OA improves physical performance (OARSI recommended physical performance measures- timed 40m walk)., Between baseline and 12 weeks.|Change in stair climb time, To determine the extent to which intra-articular (IA) injection of Zilretta vs. TA-IR in patients with dual diagnosis of T2DM and knee OA improves physical performance (OARSI recommended physical performance measures- timed stair climb)., Between baseline and 12 weeks.|Change in patient-reported physical function (KOOS-PS), To determine the extent to which intra-articular (IA) injection of Zilretta vs. TA-IR in patients with dual diagnosis ofT2DM and knee OA improves physical function (KOOS-PF). 100 point scale on which 100 is best and 0 is worst., Between baseline and 12 weeks.|Change in quality of life (KOOS-QoL), To determine the extent to which intra-articular (IA) injection of Zilretta vs. TA-IR in patients with dual diagnosis ofT2DM and knee OA improves quality of life (KOOS-QoL). 100 point scale on which 100 is best and 0 is worst., Between baseline and 12 weeks
Other Outcome Measures: Change in worst daily knee pain intensity, To determine the worst daily knee pain intensity score in the index knee (0-10 Numeric Pain Rating Scale \[NRS\]). 100 point scale on which 100 is worst pain and 0 is no pain., From baseline to Weeks 6 and 12|Change in Average Daily Pain, To determine the average daily pain score in the index knee (0-10 NRS). 10 point scale on which 0 is no pain and 10 is worst pain imaginable., From baseline to each follow-up week from 1 to 12 weeks after treatment|Effect of hyperglycemia on fatigue, To assess the acute effects of hyperglycemia on fatigue for 32 mg of ZILRETTA relative to 40 mg of TCA-IR., From baseline to time periods of 0 to 24 hours (Days 1-2); 0 to 48 hours (Days 1- 3); and 0 to 72 hours (Days 1-4), for ZILRETTA relative to TCA-IR. Diabetes Symptom Checklist - Revised (DSC-R) is scored from a low of 1 to a high of 5.|Effect of hyperglycemia on cognition, To assess the acute effects of hyperglycemia on cognition for 32 mg of ZILRETTA relative to 40 mg of TCA-IR., From baseline to time periods of 0 to 24 hours (Days 1-2); 0 to 48 hours (Days 1- 3); and 0 to 72 hours (Days 1-4), for ZILRETTA relative to TCA-IR. Diabetes Symptom Checklist - Revised (DSC-R) is scored from a low of 1 to a high of 5.|Incidence of Treatment-Emergent Adverse Events (TEAEs) and SAEs, To assess the safety and general tolerability of a single IA injection of 32 mg of ZILRETTA relative to 40 mg of TCA-IR., From baseline to Day 30