Trial Outcomes & Findings for Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes (NCT NCT02762370)
NCT ID: NCT02762370
Last Updated: 2024-01-24
Results Overview
Average blood glucose was analyzed with a mixed model for repeated measures (MMRM)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Baseline and 72 Hours post intra-articular (IA) injection
Results posted on
2024-01-24
Participant Flow
Patients were screened for study eligibility at 9 study centers in the United States (US).
Patients were Randomized within 21 days of Screening.
Participant milestones
| Measure |
FX006 32 mg
18 subjects received FX006 32 mg as a single 5 mL intra-articular (IA) injection
|
TCA IR 40 mg
15 subjects received triamcinolone acetonide injectable suspension, immediate release (TCA IR) 40 mg as a single 1 mL IA injection
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
FX006 32 mg
18 subjects received FX006 32 mg as a single 5 mL intra-articular (IA) injection
|
TCA IR 40 mg
15 subjects received triamcinolone acetonide injectable suspension, immediate release (TCA IR) 40 mg as a single 1 mL IA injection
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
FX006 32 mg
n=18 Participants
FX006: Single 5 mL IA injection
|
TCA IR 40 mg
n=15 Participants
TCA IR: Single 1 mL IA injection
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 5.76 • n=99 Participants
|
60.3 years
STANDARD_DEVIATION 10.38 • n=107 Participants
|
61.2 years
STANDARD_DEVIATION 8.08 • n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 72 Hours post intra-articular (IA) injectionAverage blood glucose was analyzed with a mixed model for repeated measures (MMRM)
Outcome measures
| Measure |
FX006 32 mg
n=18 Participants
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 Participants
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
Change From Baseline for Average Blood Glucose (mg/dL)
|
14.66 mg/dL
Standard Error 7.032
|
33.88 mg/dL
Standard Error 6.612
|
SECONDARY outcome
Timeframe: Baseline to Days 1-3The 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.
Outcome measures
| Measure |
FX006 32 mg
n=18 Participants
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 Participants
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
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
Less than 70
|
2.2 Percentage of time
|
0.4 Percentage of time
|
|
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
70 - 180
|
63.3 Percentage of time
|
49.7 Percentage of time
|
|
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
180.1 - 250.0
|
23.7 Percentage of time
|
24.5 Percentage of time
|
|
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
250.1 - 350.0
|
9.5 Percentage of time
|
21.1 Percentage of time
|
|
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
Greater than 350.0
|
1.3 Percentage of time
|
4.3 Percentage of time
|
SECONDARY outcome
Timeframe: Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)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.
Outcome measures
| Measure |
FX006 32 mg
n=18 Participants
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 Participants
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
Glycemic Variability Coeffecient of Variation (CV)
|
22.43 mg/dL
Standard Error 1.434
|
27.05 mg/dL
Standard Error 1.349
|
SECONDARY outcome
Timeframe: Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)Outcome measures
| Measure |
FX006 32 mg
n=18 Participants
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 Participants
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
Baseline (Hour -72 to Hour -1)
|
22089.0 hr*mg/dL
Standard Error 775.19
|
23669.1 hr*mg/dL
Standard Error 728.86
|
|
Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
Day 1
|
3703.3 hr*mg/dL
Standard Error 239.62
|
4483.2 hr*mg/dL
Standard Error 225.30
|
|
Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
Days 1-2
|
7902.6 hr*mg/dL
Standard Error 442.21
|
9251.7 hr*mg/dL
Standard Error 415.78
|
|
Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
Days 1-3
|
11772.3 hr*mg/dL
Standard Error 652.17
|
12950.9 hr*mg/dL
Standard Error 613.20
|
|
Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
Days 1-7
|
27245.7 hr*mg/dL
Standard Error 1615.93
|
25987.0 hr*mg/dL
Standard Error 1519.37
|
|
Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
Days 1-15
|
52112.8 hr*mg/dL
Standard Error 2966.97
|
49532.2 hr*mg/dL
Standard Error 2789.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Days 1-2Outcome measures
| Measure |
FX006 32 mg
n=18 Participants
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 Participants
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
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
Less than 70.0
|
1.2 Percentage of time
|
0.3 Percentage of time
|
|
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
70.0 - 180.0
|
64.1 Percentage of time
|
42.7 Percentage of time
|
|
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
180.1 - 250.0
|
23.0 Percentage of time
|
27.4 Percentage of time
|
|
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
250.1 - 350.0
|
9.9 Percentage of time
|
25.2 Percentage of time
|
|
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
Greater than 350.0
|
1.7 Percentage of time
|
4.4 Percentage of time
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72Outcome measures
| Measure |
FX006 32 mg
n=18 Participants
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 Participants
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
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
|
110.04 mg/dL
Standard Error 10.084
|
158.46 mg/dL
Standard Error 9.481
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48Outcome measures
| Measure |
FX006 32 mg
n=18 Participants
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 Participants
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
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.
|
16.33 mg/dL
Standard Error 8.791
|
43.62 mg/dL
Standard Error 8.255
|
Adverse Events
FX006 32 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TCA IR 40 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FX006 32 mg
n=18 participants at risk
Drug: FX006 Single intra-articular injection
FX006 32 mg
|
TCA IR 40 mg
n=15 participants at risk
Drug: TCA IR Single intra-articular injection
TCA IR 40 mg
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
0.00%
0/15 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
0.00%
0/15 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/18 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/18 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
0.00%
0/15 • Adverse Events were collected from Day 1 (following IA administration) through Day 43.
|
Additional Information
Scott Kelley, VP of Medical Affairs
Flexion Therapeutics
Phone: 781-305-7142
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place