| Trial ID: | L5459 |
| Source ID: | NCT02762370
|
| Associated Drug: |
Fx006 32 Mg
|
| Title: |
Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02762370/results
|
| Conditions: |
Osteoarthritis of the Knee|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: FX006 32 mg|DRUG: TCA IR 40 mg
|
| Outcome Measures: |
Primary: Change From Baseline for Average Blood Glucose (mg/dL), Average blood glucose was analyzed with a mixed model for repeated measures (MMRM), Baseline and 72 Hours post intra-articular (IA) injection | Secondary: 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., Baseline to Days 1-3|Glycemic Variability Coeffecient of Variation (CV), 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., Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)|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) | Other: 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 1-2|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, Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72|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., Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48
|
| Sponsor/Collaborators: |
Sponsor: Pacira Pharmaceuticals, Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
33
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04
|
| Completion Date: |
2016-11
|
| Results First Posted: |
2018-01-26
|
| Last Update Posted: |
2024-01-24
|
| Locations: |
Anaheim, California, 92801, United States|El Cajon, California, 92020, United States|North Hollywood, California, 91606, United States|Duncansville, Pennsylvania, 16635, United States|Mount Pleasant, South Carolina, 29464, United States|Knoxville, Tennessee, 37938, United States|Dallas, Texas, 75231, United States|San Antonio, Texas, 78258, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02762370
|
