Clinical trial NCT02762370 (phase 2, status: completed)
Conditions: osteoarthritis of the knee, type 2 diabetes mellitus
ICD codes: M15.4, M15.0, M16.9, M17.9, M19.011, M19.012, M19.019, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: fx006 32 mg, tca ir 40 mg
SMILES: OC(=O)C1=CC2=C(C=C1)N=C(O2)C1=CC(Cl)=CC(Cl)=C1, [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
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