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

Primary Purpose

Osteoarthritis of the Knee, Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

FX006 32 mg

TCA IR 40 mg

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, pain, diabetes, intra-articular, injection, corticosteroid

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FX006 32 mg

TCA IR 40 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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.

Glycemic Variability Coeffecient of Variation (CV)

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

Full Information

NCT ID

NCT02762370

First Posted

May 3, 2016

Last Updated

December 27, 2017

Sponsor

Flexion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02762370

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Flexion Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee, Type 2 Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FX006 32 mg

Arm Type

Experimental

Arm Description

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

Arm Title

TCA IR 40 mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

FX006 32 mg

Other Intervention Name(s)

Zilretta

Intervention Description

Single 5 mL IA injection

Intervention Type

Drug

Intervention Name(s)

TCA IR 40 mg

Other Intervention Name(s)

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

Intervention Description

Single 1 mL IA injection

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Days 1-3

Title

Glycemic Variability Coeffecient of Variation (CV)

Description

Time Frame

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

Title

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 Pre-specified Outcome Measures:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Bodick, MD

Organizational Affiliation

Flexion Therapeutics

Official's Role

Study Director

Facility Information:

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37938

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30203101

Citation

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.

Results Reference

derived

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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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