Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes
Condition: Osteoarthritis of the Knee; Type 2 Diabetes Mellitus
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: FX006 32 mg; TCA IR 40 mg
Intervention description: Single 5 mL IA injection; Single 1 mL IA injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; FX006; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee; pain; diabetes; intra-articular; injection; corticosteroid

Summary:

      The purpose of this study was to compare the effects of FX006 and Triamcinolone Acetonide
      Injectable Suspension, United States Pharmacopeia (USP) (referred to as TCA IR in the
      protocol) on blood glucose (BG) in patients with osteoarthritis (OA) of the knee and Type 2
      diabetes mellitus (DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willingness and ability to comply with the study procedures and visit schedules and
             ability to follow verbal and written instructions

          -  Male or female ≥40 years of age

          -  Type 2 diabetes mellitus for at least 1 year prior to Screening and not managed with
             injectable agents (e.g. insulin or insulin analogs, exenatide, pramlintide,
             liraglutide)

          -  Currently treated with 1 or 2 oral agents for diabetes, with stable doses for at least
             2 months

          -  HbA1c ≥6.5% and ≤ 9.0%

          -  Currently meets American College of Rheumatology (ACR) Criteria (clinical or
             radiological) for OA.

          -  Symptoms associated with OA of the knee for ≥ 6 months prior to Screening

          -  Index knee pain on most days (>15) over the last month (as reported by the patient)

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Willingness to abstain from use of protocol-specified restricted medications during
             the study

          -  Willingness to wear a CGM device uninterrupted for 24 hours per day throughout the
             study, remain with receiving range and comply with calibration requirements

          -  Accustomed to using a Standard Blood Glucose Measuring device by finger stick

        Exclusion Criteria:

          -  Reiter's syndrome, 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

          -  Unstable joint (such as a torn anterior cruciate ligament) within 12 months of
             screening

          -  IA corticosteroid (investigational or marketed) in any joint within 3 months of
             Screening

          -  IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of
             Screening

          -  IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months
             of Screening

          -  Oral corticosteroids (investigational or marketed) within 1 month of Screening

          -  Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2
             weeks of Screening

          -  Any other IA investigational drug/biologic within 6 months of Screening

          -  Prior use of FX006

          -  Use of acetaminophen, or acetaminophen containing products

          -  Current use of a continuous glucose monitoring device

          -  Women of child-bearing potential not using effective contraception or who are pregnant
             or nursing