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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Change From Baseline for Average Blood Glucose (mg/dL)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TCA IR 40 mg
Single 1 mL intra-articular (IA) injection Immediate-release Formulation
干预措施: TCA IR 40 mg (Drug)
FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release Formulation
干预措施: FX006 32 mg (Drug)
结局指标
主要结局
Change From Baseline for Average Blood Glucose (mg/dL)
时间窗: Baseline and 72 Hours post intra-articular (IA) injection
Average blood glucose was analyzed with a mixed model for repeated measures (MMRM)
次要结局
- Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR(Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose))
- 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(Baseline to Days 1-3)
- Glycemic Variability Coeffecient of Variation (CV)(Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period))