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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 12 visits, 4 visits, 2 visits
  • Procedures mentioned: Injections, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects who meet all eligibility criteria but are found to have insufficient BG data at their Day 1 visit (ie, missing CGM data ≥ 30%) may repeat the full 7-day pretreatment phase at the discretion of the PI."
  • "BG Monitoring and Management of T2DM During the Trial After a Screening visit, BG levels in each subject will be measured using a CGM device, for at least 10 days pre-injection (pretreatment period) and for at least 10 days postinjection (post-treatment)."
  • "The study will involve between 6-12 outpatient visits (depending on whether selected for salivary cortisol tesing) and up to 4 phone visits that will include Screening, a Pretreatment visit (Day -14 where the CGM sensor will be placed to initiate study BG data collection), Day 1 (Baseline and treatment), and 2 Posttreatment visits (Days 43, and 85)."
  • "Recovery of the HPA axis to Baseline normally occurs within 1-4 weeks but can be longer in consideration of the dose and frequency of injections (Habib, 2009)."
  • "However, after single IA dose of GC injection recovery after 1-2 weeks was observed in most of the patients (Mader et al, 2005)."
  • "Intra-Articular Injection On Day 1 (Treatment Day), IA injections will be administered by the assigned blinded, trained injector, who has experience in the administration of IA injections and has been trained on study administration procedures."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how Zilretta, a slow-release steroid, and Kenalog, a quick-release steroid, affect blood sugar. It is for adults age 40 or older with type 2 diabetes managed without insulin and painful knee osteoarthritis, or wear-and-tear arthritis. Each person takes part for about 4 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 40 or older, give written consent, and be able to follow study directions and visit schedules.
  • Have type 2 diabetes for at least 1 year. Use diabetes medicine other than insulin, with doses unchanged for at least 1 month.
  • Have an HbA1c of 6.5–9%, a test of average blood sugar, within the past 8 weeks.
  • Have a kidney filter test called eGFR of at least 50 and triglycerides, a blood fat, below 500 mg/dL within the past 8 weeks.
  • Have knee arthritis pain for at least 6 months, rated 4–9 out of 10 on most days in the past month. The study knee must hurt on more than 15 days of that month.
  • Have knee arthritis confirmed by an exam and X-rays, with an X-ray grade of 2–4, bone spurs, and either stiffness lasting under 30 minutes or a grinding feeling.
  • Wear a blood sugar sensor all day and night when required, and check blood sugar as directed. At least 70% of the needed sensor data must be collected before treatment.
  • For women: have a negative pregnancy test, not breastfeed, and not plan pregnancy during the study.

Who can't join

  • Have certain other types of arthritis, a past infection in the study knee, recent knee infection or crystal-related arthritis, hardware in that knee, or an unstable knee within the past year.
  • Have moderate or severe kidney, liver, or thyroid disease; glaucoma; certain hormone disorders; sarcoidosis or amyloidosis; or another condition the study doctor considers unsafe.
  • Have active cancer or cancer within the past 3 years, except certain treated skin or cervical cancers.
  • Have certain infections, including HIV, hepatitis B or C, or a past bone infection. Recent infections needing antibiotics, or broken skin at the knee injection site, also rule out joining.
  • Have used steroids too recently, expect to need steroids during the study, or have an allergy to triamcinolone, the steroid in both study drugs. Other recent joint injections or experimental joint treatments may also rule out joining.
  • Have had surgery on the study knee within the past year, or expect any surgery during the study.
  • Use acetaminophen from screening through day 14, take Coumadin with an INR blood-clotting test of 5 or higher, have used certain immune-system or cancer drugs within 2 years, or have received a live vaccine within 3 months.
  • Have current drug or alcohol abuse, long-term abuse within the past year, or past long-term abuse the study doctor thinks may return.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 Screening. 7\. HbA1c 6.5-9% (in past 8 weeks). 8. Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2. (in past 8 weeks) 9. Triglycerides \<500 mg/dL (in past 8 weeks) 10. Painful symptoms associated with OA of the knee for ≥6 months prior to Screening (NRS of 4-9 during most of the 30 days prior to enrollment). 11\. Currently meets modified ACR criteria (clinical and radiological) for OA (Altman et al, 1986) as follows: 1. Knee pain 2. At least 1 of the following: * Stiffness \<30 minutes * Crepitus 3. Osteophytes 12. Index knee pain more than 15 days over the last month (as reported by the subject). 13\. Kellgren-Lawrence Grade 2-4. 14. Willingness to wear a CGM device uninterrupted for 24 hours per day throughout the required time during the study and comply to the correct use requirements of CGM throughout the trial and perform self BG checks as directed. 15\. Adequate BG data collected during the pretreatment phase (Day -10 through Day -1) ≥70% data available. Exclusion Criteria: Disease-related Criteria 1. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease. 2. History of infection in the index knee joint. 3. Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening. 4. Presence of surgical hardware or other foreign body in the index knee. 5. Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening. 6. Moderate or severe kidney, liver, or thyroid disease. 7. Glaucoma. 8. Active cancer. Previous or Concomitant Treatment-related Criteria 9. IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening. 10. IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening. 11. IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening. 12. Oral corticosteroids (investigational or marketed) within 1 month of Screening. 13. Inhaled, intranasal, or topical corticosteroids (investigational or marketed) within 2 weeks of Screening. 14. Any other IA investigational device, drug/biologic within 6 months of Screening or 5 half-lives (whichever is longer). 15. Prior arthroscopic or open surgery of the index knee within 12 months of Screening. 16. Planned/anticipated surgery of the index knee or any other surgery during the study period. 17. Use of acetaminophen, or acetaminophen-containing products, from Screening through Day 14 (completion of post-treatment BG monitoring). 18. Subjects on Coumadins with INR ≥5 will be excluded (Bashir et al, 2015) Subject-related Criteria 19. Known hypersensitivity to any form of triamcinolone. 20. History of sarcoidosis or amyloidosis. 21. Active or history of malignancy within the last 3 years, except for resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively managed cervical carcinoma. 22. Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral, or parasitic infections or ocular herpes simplex. 23. Any infection requiring IV antibiotics within 4 weeks of Screening or infection requiring oral antibiotics within 2 weeks of Screening. 24. History of osteomyelitis. 25. Known or clinically suspected infection with human immunodeficiency virus (HIV) or hepatitis B or C viruses. 26. Requiring or likely to require treatment with corticosteroids during the study period based on subject medical history. 27. History or active Cushing's or Addison's syndrome. 28. Active substance abuse (drugs or alcohol), history of chronic substance abuse within the last year, or prior chronic substance abuse judged by the Investigator likely to recur during the study. 29. Skin breakdown at the knee where the injection would take place. 30. Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 2 years of Screening. 31. Receipt of a live or live attenuated vaccine within 3 months of Screening. 32. Any other clinically significant psychiatric acute or chronic medical conditions that, in the judgment of the Investigator, would preclude the use of an IA corticosteroid or NSAIDs or that could compromise subject safety, limit the subject's ability to complete or adhere to the study, and/or compromise the objectives of the study.

Study sites (1)

KS