Conditions: Osteoarthritis of the Knee Type 2 Diabetes Mellitus
Keywords: osteoarthritis knee pain diabetes intra-articular injection corticosteroid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

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.

Arms:
arm 1: Single 5 mL intra-articular (IA) injection Extended-release Formulation arm 2: Single 1 mL intra-articular (IA) injection Immediate-release Formulation

Interventions: intervention 1: FX006 32 mg intervention 2: TCA IR 40 mg
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 1 mL IA injection

Protocol document: