Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes

NCT02762370 | Completed Phase 2 Results

• 1 other identifier: FX006-2015-010
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Osteoarthritis of the Knee; Type 2 Diabetes Mellitus

Keywords

osteoarthritis; knee; pain; diabetes; intra-articular; injection; corticosteroid

Outcome Measures

Primary Outcomes (1)

• Change From Baseline for Average Blood Glucose (mg/dL)

  Average blood glucose was analyzed with a mixed model for repeated measures (MMRM)

  Baseline and 72 Hours post intra-articular (IA) injection

Secondary Outcomes (3)

• Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl

  Baseline to Days 1-3

• Glycemic Variability Coeffecient of Variation (CV)

  Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)

• Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR

  Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)

Other Outcomes (3)

• Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl

  Baseline to Days 1-2

• Change From Baseline for Maximum Blood Glucose: Baseline Average Blood Glucose (Hour -72 to Hour -1) to Maximum Blood Glucose (Hour 1 to Hour 72) for FX006 32 mg Relative to TCA IR 40 mg

  Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72

• Change in Average Blood Glucose From Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48 for FX006 32 mg Relative to TCA IR 40 mg.

  Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48

Study Arms (2)

FX006 32 mg

EXPERIMENTAL

Single 5 mL intra-articular (IA) injection Extended-release Formulation

Drug: FX006 32 mg

TCA IR 40 mg

ACTIVE COMPARATOR

Single 1 mL intra-articular (IA) injection Immediate-release Formulation

Drug: TCA IR 40 mg

Interventions

FX006 32 mg DRUG

Single 5 mL IA injection

Also known as: Zilretta

FX006 32 mg

TCA IR 40 mg DRUG

Single 1 mL IA injection

Also known as: Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)

TCA IR 40 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (8)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

El Cajon, California, 92020, United States

Location

Unknown Facility

North Hollywood, California, 91606, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Knoxville, Tennessee, 37938, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

San Antonio, Texas, 78258, United States

Location

Related Publications (1)

• Russell SJ, Sala R, Conaghan PG, Habib G, Vo Q, Manning R, Kivitz A, Davis Y, Lufkin J, Johnson JR, Kelley S, Bodick N. Triamcinolone acetonide extended-release in patients with osteoarthritis and type 2 diabetes: a randomized, phase 2 study. Rheumatology (Oxford). 2018 Dec 1;57(12):2235-2241. doi: 10.1093/rheumatology/key265.

  PMID: 30203101 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Diabetes Mellitus, Type 2; Osteoarthritis; Pain; Diabetes Mellitus

Interventions

FX006; Triamcinolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Subsequent to completion of clinical studies extensive testing was performed to assess the actual FX006 dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg.

Results Point of Contact

• Title: Scott Kelley, VP of Medical Affairs
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Neil Bodick, MD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 24, 2024
• Results First Posted: January 26, 2018

Record last verified: 2024-01

Locations

US (8)