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Osteoarthritis of the KneePhase 2NCT02762370

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

A Phase 2 study testing FX006 32 mg and TCA IR 40 mg in people with Osteoarthritis of the Knee and Type 2 Diabetes Mellitus, run by Pacira Pharmaceuticals, Inc at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
FX006 32 mg and TCA IR 40 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
8 sitesUnited States
Study dates
Apr 2016to Nov 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Dallas, Texas, 75231

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    El Cajon, California, 92020

  • Study site

    Knoxville, Tennessee, 37938

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    North Hollywood, California, 91606

  • Study site

    San Antonio, Texas, 78258

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
FX006 32 mg, TCA IR 40 mg
Keywords
osteoarthritis, knee, pain, diabetes, intra-articular, injection, corticosteroid
Medical subject headings
Osteoarthritis, Knee, Diabetes Mellitus, Type 2, Osteoarthritis, Pain, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FX006 32 mgDrug

    Also called Zilretta

    Single 5 mL IA injection

  • TCA IR 40 mgDrug

    Also called Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)

    Single 1 mL IA injection

Study groups in NCT02762370
Study groupRoleWhat they receive
FX006 32 mgExperimentalSingle 5 mL intra-articular (IA) injection Extended-release Formulation
Receives: Drug: FX006 32 mg
TCA IR 40 mgActive comparatorSingle 1 mL intra-articular (IA) injection Immediate-release Formulation
Receives: Drug: TCA IR 40 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

Secondary outcomes (3)

  1. 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

    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.

    Measured: Baseline to Days 1-3

  2. Glycemic Variability Coeffecient of Variation (CV)

    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.

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionOct 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02762370
Sponsor's protocol ID
FX006-2015-010
Status last verified
Jan 2024
First submitted
3 May 2016
Last updated
24 Jan 2024
Data monitoring committee
No

Publications

  • 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.

    PubMed 30203101

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FX006 32 mg and TCA IR 40 mg in people with Osteoarthritis of the Knee and Type 2 Diabetes Mellitus, run by Pacira Pharmaceuticals, Inc at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline for Average Blood Glucose (mg/dL) (time frame: Baseline and 72 Hours post intra-articular (IA) injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02762370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

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