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

January 22, 2024 updated by: Pacira Pharmaceuticals, Inc

A Double-Blind, Randomized, Parallel Group Comparison of the Effects of FX006 and TCA IR (Triamcinolone Acetonide Suspension) on Blood Glucose in Patients With Osteoarthritis of the Knee and Type 2 Diabetes Mellitus

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study employed a double-blind, randomized, parallel group, single dose design to explore the pharmacodynamic effects on BG levels in type 2 diabetics following IA administration of 32 mg FX006 compared to 40 mg TCA IR. The study was conducted in male and female patients ≥40 years of age with OA of the knee and type 2 DM not managed by injectable agents. In order to be eligible for study participation, patients were to be treated with 1 or 2 oral agents and have hemoglobin A1c (HbA1c) levels between 6.5%-9.0%.

Approximately 36 patients were planned to be randomized and treated to ensure there were at least 30 evaluable patients (15 patients on FX006 and 15 patients on TCA IR). Patients were randomized to 1 of 2 treatment groups (1:1) and treated with a single IA injection of either:

  • 32 mg FX006 (18 patients) or
  • 40 mg TCA IR (18 patients)

BG levels in each patient were evaluated for a total of 3 weeks (1 week prior to IA injection and 2 weeks post IA injection). After a screening visit, patients' BG levels were measured using a Dexcom Z4 Platinum Professional™ continuous glucose monitor (CGM) device, set to blinded mode, for up to 1 week pre-injection and for 2 weeks post injection using the same blinded CGM device. Patients also were provided with a Bayer Contour™ standard glucose measuring meter in order to perform the necessary calibrations per the manufacturer's recommendations. A final safety visit was planned at 6 weeks post-injection.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
      • El Cajon, California, United States, 92020
      • North Hollywood, California, United States, 91606
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Knoxville, Tennessee, United States, 37938
    • Texas
      • Dallas, Texas, United States, 75231
      • San Antonio, Texas, United States, 78258

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.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release Formulation
Drug: FX006 32 mg
Single 5 mL IA injection
Other Names:
  • Zilretta
Active Comparator: TCA IR 40 mg
Single 1 mL intra-articular (IA) injection Immediate-release Formulation
Drug: TCA IR 40 mg
Single 1 mL IA injection
Other Names:
  • Kenalog®-40 Injection
  • Triamcinolone Acetonide Crystalline Suspension (TAcs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline for Average Blood Glucose (mg/dL)
Time Frame: Baseline and 72 Hours post intra-articular (IA) injection
Average blood glucose was analyzed with a mixed model for repeated measures (MMRM)
Baseline and 72 Hours post intra-articular (IA) injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline to Days 1-3
The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average.
Baseline to Days 1-3
Glycemic Variability Coeffecient of Variation (CV)
Time Frame: Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)
The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average.
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
Time Frame: Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)
Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)

Other Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline to Days 1-2
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
Time Frame: Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72
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.
Time Frame: Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48
Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacira Pharmaceuticals, Inc

Investigators

  • Study Director: Neil Bodick, MD, Flexion Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimated)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FX006-2015-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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