This trial is active, not recruiting.

Conditions osteoarthritis of the knee, type 2 diabetes mellitus
Treatments fx006 40 mg, tca ir 40 mg
Phase phase 2
Sponsor Flexion Therapeutics, Inc.
Start date April 2016
End date November 2016
Trial size 36 participants
Trial identifier NCT02762370, FX006-2015-010


This study is a double-blind, randomized, parallel group comparison of the effects of FX006 and Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in the protocol) on blood glucose in patients with osteoarthritis of the knee and Type 2 diabetes mellitus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose diagnostic
Drug: FX006 Single intra-articular injection
fx006 40 mg Zilretta ™
(Active Comparator)
Drug: TCA IR Single intra-articular injection
tca ir 40 mg Kenalog

Primary Outcomes

Average blood glucose
time frame: 72 Hours post IA injection

Secondary Outcomes

Mean blood glucose levels
time frame: 1 and 2 weeks post IA Injection
Percent time blood glucose less than 70 mg/dl, between 70 and 180 mg/dl, greater than 180 mg/dl and greater than 250 mg/dl
time frame: 24 hours post IA injection, 1 week and 2 weeks post IA injection
Glycemic variability coefficient of variation (CV)
time frame: 24 hours post IA injection, 1 week and 2 weeks post IA injection
Glycemic variability (SD)
time frame: 24 hours post IA injection, 1 week and 2 weeks post IA injection

Eligibility Criteria

Male or female participants at least 40 years old.

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, liraglutid) - 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 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 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

Additional Information

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
Description This study is a double-blind, randomized, parallel group, single-dose study design. The study will be conducted in male and female patients ≥ 40 years of age with osteoarthritis of the knee and Type 2 diabetes mellitus. Approximately 36 patients will be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of: - 40 mg FX006 or - 40 mg TCA IR Blood glucose levels will be evaluated for a total of 3 weeks (one week prior to injection and two weeks post IA injection) using a continuous glucose monitoring device. Following randomization and IA injection, patients will return for follow up visits at Day 8, Day 15 and Week 6/Day 43.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Flexion Therapeutics, Inc..