Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Kansas Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
1. Written consent to participate in the study. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
Knee pain
Stiffness <30 minutes
Crepitus
Disqualifiers
Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
History of infection in the index knee joint.
Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening.
Presence of surgical hardware or other foreign body in the index knee.
Trial design
Design model
Parallel
Treatments tested in this trial
triamcinolone acetonide extended-release injectable suspension; TCA-ER
DrugMode 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
DrugMode of Administration: IA Knee Injection Triamcinolone Acetonide- Immediate Release (TCA-IR)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: TA-ERActive comparator 1 intervention
Group B: TA-IRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The primary outcome will be measured up to 72 hours after treatment by a sensor automatically uploading the dataSecondary outcomes
1
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.
Time frame
From baseline until the end-of-study (Day 85).2
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.
Time frame
From baseline throughout 10 days follow-up.3
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.
Time frame
From baseline throughout 10 days follow-up4
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).
Time frame
Between baseline and 12 weeks.Other outcomes
1
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.
Time frame
From baseline to Weeks 6 and 122
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.
Time frame
From baseline to each follow-up week from 1 to 12 weeks after treatment3
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.
Time frame
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 5.4
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov