RECRUITING

Knee Osteoarthritis Treatment with Zilretta Vs. Kenalog in the Context of Type II Diabetes

Conditions

Osteoarthritis, Knee Diabetes Mellitus, Type 2 Zilretta Kenalog

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-16

Study Completion:2026-07-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06478186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Jeannine Nilges, MD

CONTACT

913-574-0961

jnilges@kumc.edu

Principal Investigator

Neil A Segal, MD, MS

PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Neil A Segal, MD, MS, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-16

Study Completion Date2026-07-16

Study Record Updates

Study Start Date2024-08-16

Study Completion Date2026-07-16

Terms related to this study

Keywords Provided by Researchers

Zilretta
Kenalog

Additional Relevant MeSH Terms

Osteoarthritis, Knee
Diabetes Mellitus, Type 2