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Trial record 53 of 75 for:    "Collagen Disease" | "Triamcinolone"

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

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ClinicalTrials.gov Identifier: NCT02762370
Recruitment Status : Completed
First Posted : May 4, 2016
Results First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Type 2 Diabetes Mellitus Drug: FX006 32 mg Drug: TCA IR 40 mg Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016


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 Name: 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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  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 [ 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.

  2. 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.

  3. 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) ]

Other Outcome Measures:
  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 [ Time Frame: Baseline to Days 1-2 ]
  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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762370


Locations
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United States, California
Anaheim, California, United States, 92801
El Cajon, California, United States, 92020
North Hollywood, California, United States, 91606
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Knoxville, Tennessee, United States, 37938
United States, Texas
Dallas, Texas, United States, 75231
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Neil Bodick, MD Flexion Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02762370     History of Changes
Other Study ID Numbers: FX006-2015-010
First Posted: May 4, 2016    Key Record Dates
Results First Posted: January 26, 2018
Last Update Posted: January 26, 2018
Last Verified: December 2017

Keywords provided by Flexion Therapeutics, Inc.:
osteoarthritis
knee
pain
diabetes
intra-articular
injection
corticosteroid

Additional relevant MeSH terms:
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Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Diabetes Mellitus
Diabetes Mellitus, Type 2
Osteoarthritis
Osteoarthritis, Knee
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action