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
University of Kansas Medical Center
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.
Description
Protocol Title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of ZILRETTA (Triamcinolone Acetonide-Extended Release) and TA-IR (Triamcinolone Acetonide-Immediate Release) on Blood Glucose Levels in Subjects with Osteoarthritis of the Knee and Type 2 Diabetes Mellitus Brief Title: Zilretta Diabetic Knee OA Regulatory Agency Identifier Number(s): IND 111325 Test Product, Dose, Mode of Administration, and Lot Number Name: ZILRETTA (triamcinolone acetonide extended-release injectable suspension; TA-ER) Active ingredient: Extended-release formulation of TA in 75:25 pol…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. 3\. Male or female ≥40 years of age. 4. Females with negative pregnancy test, who are not breastfeeding and have no intention to become pregnant during the time from screening through EOS. 5\. Type 2 DM for at least 1 year prior to Screening. 6. Currently being treated with injectable (except insulin) and/or oral antidiabetic agents with stable doses for at least 1 month prior to S…
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)
Location
- University of Kansas Medical CenterKansas City, Kansas