Trial Outcomes & Findings for Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes (NCT NCT02964585)
NCT ID: NCT02964585
Last Updated: 2022-12-07
Results Overview
To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis.
COMPLETED
PHASE4
34 participants
16 weeks post Canagliflozin treatment reported
2022-12-07
Participant Flow
Participant milestones
| Measure |
Active Arm
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.64 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
59.15 years
STANDARD_DEVIATION 11.24 • n=7 Participants
|
57.72 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
BMI
|
30.71 kg/m^2
STANDARD_DEVIATION 1.41 • n=5 Participants
|
33.11 kg/m^2
STANDARD_DEVIATION 1.08 • n=7 Participants
|
31.55 kg/m^2
STANDARD_DEVIATION 0.92 • n=5 Participants
|
|
Body Fat Percentage
|
32.92 percentage of body fat
STANDARD_DEVIATION 2.39 • n=5 Participants
|
39.65 percentage of body fat
STANDARD_DEVIATION 2.64 • n=7 Participants
|
36.14 percentage of body fat
STANDARD_DEVIATION 1.86 • n=5 Participants
|
|
HbA1C
|
8.39 percentage of hemoglobin
STANDARD_DEVIATION 0.36 • n=5 Participants
|
7.93 percentage of hemoglobin
STANDARD_DEVIATION 0.33 • n=7 Participants
|
8.14 percentage of hemoglobin
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
eGFR
|
80.24 mL/min
STANDARD_DEVIATION 4.27 • n=5 Participants
|
85.22 mL/min
STANDARD_DEVIATION 4.43 • n=7 Participants
|
82.43 mL/min
STANDARD_DEVIATION 3.08 • n=5 Participants
|
|
Creatinine
|
0.96 mg/dL
STANDARD_DEVIATION 0.05 • n=5 Participants
|
0.84 mg/dL
STANDARD_DEVIATION 0.05 • n=7 Participants
|
0.90 mg/dL
STANDARD_DEVIATION 0.04 • n=5 Participants
|
|
HDL
|
42.96 mg/dL
STANDARD_DEVIATION 3.47 • n=5 Participants
|
51.56 mg/dL
STANDARD_DEVIATION 3.60 • n=7 Participants
|
47.0 mg/dL
STANDARD_DEVIATION 2.50 • n=5 Participants
|
|
Total Cholesterol
|
167.78 mg/dL
STANDARD_DEVIATION 9.74 • n=5 Participants
|
163.40 mg/dL
STANDARD_DEVIATION 10.09 • n=7 Participants
|
166.60 mg/dL
STANDARD_DEVIATION 7.08 • n=5 Participants
|
|
LDL/HDL
|
2.19 unitless (ratio)
STANDARD_DEVIATION 0.15 • n=5 Participants
|
1.68 unitless (ratio)
STANDARD_DEVIATION 0.15 • n=7 Participants
|
1.94 unitless (ratio)
STANDARD_DEVIATION 0.13 • n=5 Participants
|
|
C-reactive Protein
|
0.54 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.03 mg/dL
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.79 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Insulin
|
2.50 mg/dL
STANDARD_DEVIATION 0.20 • n=5 Participants
|
2.49 mg/dL
STANDARD_DEVIATION 0.21 • n=7 Participants
|
2.50 mg/dL
STANDARD_DEVIATION 0.20 • n=5 Participants
|
|
Augmentation Index
|
24.2 Percent Aug pressure of Pulse Pressure
STANDARD_DEVIATION 2.8 • n=5 Participants
|
22.1 Percent Aug pressure of Pulse Pressure
STANDARD_DEVIATION 2.9 • n=7 Participants
|
22.95 Percent Aug pressure of Pulse Pressure
STANDARD_DEVIATION 1.94 • n=5 Participants
|
|
Pulse wave velocity
|
9.59 m/s
STANDARD_DEVIATION 0.66 • n=5 Participants
|
11.19 m/s
STANDARD_DEVIATION 0.64 • n=7 Participants
|
10.81 m/s
STANDARD_DEVIATION 0.40 • n=5 Participants
|
|
Leptin
|
28.36 ug/dL
STANDARD_DEVIATION 3.30 • n=5 Participants
|
39.84 ug/dL
STANDARD_DEVIATION 3.34 • n=7 Participants
|
33.29 ug/dL
STANDARD_DEVIATION 4.02 • n=5 Participants
|
|
SDF-1a
|
5.49 pg/mL
STANDARD_DEVIATION 0.46 • n=5 Participants
|
6.34 pg/mL
STANDARD_DEVIATION 0.47 • n=7 Participants
|
5.92 pg/mL
STANDARD_DEVIATION 0.46 • n=5 Participants
|
|
3-hydroxy-butyric acid
|
0.01 mmol/mol Creatinine
STANDARD_DEVIATION 0.01 • n=5 Participants
|
0.03 mmol/mol Creatinine
STANDARD_DEVIATION 0.01 • n=7 Participants
|
0.01 mmol/mol Creatinine
STANDARD_DEVIATION 0.02 • n=5 Participants
|
|
Acetoacetic Acid
|
1.08 mmol/mol Creatinine
STANDARD_DEVIATION 0.24 • n=5 Participants
|
0.72 mmol/mol Creatinine
STANDARD_DEVIATION 0.25 • n=7 Participants
|
0.90 mmol/mol Creatinine
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
Mean MNC
|
147.75 cells*10^6/mL
STANDARD_DEVIATION 15.54 • n=5 Participants
|
167.00 cells*10^6/mL
STANDARD_DEVIATION 16.08 • n=7 Participants
|
157.04 cells*10^6/mL
STANDARD_DEVIATION 10.41 • n=5 Participants
|
|
%CD34+
|
0.94 percentage of MNCs
STANDARD_DEVIATION 0.19 • n=5 Participants
|
1.01 percentage of MNCs
STANDARD_DEVIATION 0.19 • n=7 Participants
|
0.98 percentage of MNCs
STANDARD_DEVIATION 0.18 • n=5 Participants
|
|
Nephrin
|
5.39 ug/dL
STANDARD_DEVIATION 0.51 • n=5 Participants
|
6.15 ug/dL
STANDARD_DEVIATION 0.55 • n=7 Participants
|
5.77 ug/dL
STANDARD_DEVIATION 0.54 • n=5 Participants
|
|
PODXL
|
7.05 ug/dL
STANDARD_DEVIATION 0.31 • n=5 Participants
|
6.72 ug/dL
STANDARD_DEVIATION 0.33 • n=7 Participants
|
6.89 ug/dL
STANDARD_DEVIATION 0.31 • n=5 Participants
|
|
Colony Forming Units
|
6.08 CFU
STANDARD_DEVIATION 1.95 • n=5 Participants
|
10.30 CFU
STANDARD_DEVIATION 2.03 • n=7 Participants
|
8.14 CFU
STANDARD_DEVIATION 0.98 • n=5 Participants
|
|
Blood Pressure
Systolic
|
125.79 mmHg
STANDARD_DEVIATION 3.07 • n=5 Participants
|
125.77 mmHg
STANDARD_DEVIATION 5.28 • n=7 Participants
|
125.78 mmHg
STANDARD_DEVIATION 2.98 • n=5 Participants
|
|
Blood Pressure
Diastolic
|
81.14 mmHg
STANDARD_DEVIATION 2.04 • n=5 Participants
|
74.92 mmHg
STANDARD_DEVIATION 1.94 • n=7 Participants
|
78.34 mmHg
STANDARD_DEVIATION 1.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedTo determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis.
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
CXCL12 Expression
|
0.63 ng/mL in serum
Standard Deviation 0.18
|
0.33 ng/mL in serum
Standard Deviation 0.17
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
CXCR4 Expression
|
1.58 ng/mL in serum
Standard Deviation 0.18
|
0.90 ng/mL in serum
Standard Deviation 0.18
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
EDN1
|
2.10 ng/mL in serum
Standard Deviation 0.27
|
1.03 ng/mL in serum
Standard Deviation 0.29
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
VEGEF-A
|
1.12 ng/mL in serum
Standard Deviation 0.19
|
0.83 ng/mL in serum
Standard Deviation 0.19
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
PECAM
|
1.28 ng/mL in serum
Standard Deviation 0.12
|
0.89 ng/mL in serum
Standard Deviation 0.12
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
KDR
|
1.16 ng/mL in serum
Standard Deviation 0.2
|
0.5 ng/mL in serum
Standard Deviation 0.2
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
NOS3
|
0.34 ng/mL in serum
Standard Deviation 0.21
|
-0.25 ng/mL in serum
Standard Deviation 0.21
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
Catalase
|
0.20 ng/mL in serum
Standard Deviation 0.26
|
-0.61 ng/mL in serum
Standard Deviation 0.26
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
GPX35
|
2.25 ng/mL in serum
Standard Deviation 0.54
|
1.71 ng/mL in serum
Standard Deviation 0.54
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
SDF 10 NG
|
0.26 ng/mL in serum
Standard Deviation 0.03
|
0.23 ng/mL in serum
Standard Deviation 0.03
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
SOD2
|
1.36 ng/mL in serum
Standard Deviation 0.24
|
0.92 ng/mL in serum
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedTo determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis.
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Percentages)
Percent of CD34+
|
0.93 percentage of MNCs
Standard Deviation 0.17
|
1.23 percentage of MNCs
Standard Deviation 0.21
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Percentages)
Percent of CD31+
|
2.58 percentage of MNCs
Standard Deviation 0.35
|
2.16 percentage of MNCs
Standard Deviation 0.43
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Percentages)
Percent CD34+ and CD184+
|
0.37 percentage of MNCs
Standard Deviation 0.09
|
0.61 percentage of MNCs
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedTo determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis.
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Counts)
Mean MNC count
|
155.09 cells*10^6/mL
Standard Deviation 15.54
|
155.09 cells*10^6/mL
Standard Deviation 16.08
|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Counts)
Mean CD34+ve cell count (x100)
|
2682.93 cells*10^6/mL
Standard Deviation 491.44
|
3157.36 cells*10^6/mL
Standard Deviation 508.69
|
PRIMARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedTo determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis.
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Proliferation)
|
7.53 Colony forming units (CFU)
Standard Deviation 1.89
|
13.69 Colony forming units (CFU)
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: measured at 8 and 16 (reported) weeks post treatmentIL-6, and TNF-alpha
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Serum Endothelial Inflammatory Markers (1)
IL-6
|
4.56 pg/mL
Standard Deviation 4.91
|
3.21 pg/mL
Standard Deviation 1.82
|
|
Serum Endothelial Inflammatory Markers (1)
TNF-alpha
|
1.36 pg/mL
Standard Deviation 0.34
|
1.63 pg/mL
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)Measured from a serum blood Lipid Panel: cholesterol and serum ketone bodies
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Fasting Lipid Profile
LDL
|
96.03 mg/dL
Standard Deviation 6.93
|
82.672 mg/dL
Standard Deviation 8.27
|
|
Fasting Lipid Profile
Cholesterol
|
171.57 mg/dL
Standard Deviation 9.84
|
147.76 mg/dL
Standard Deviation 10.61
|
|
Fasting Lipid Profile
HDL
|
46.17 mg/dL
Standard Deviation 3.48
|
51.67 mg/dL
Standard Deviation 3.69
|
|
Fasting Lipid Profile
3-hydroxybutyric acid (ketone body)
|
0.02 mg/dL
Standard Deviation 0.01
|
0.03 mg/dL
Standard Deviation 0.01
|
|
Fasting Lipid Profile
Acetoacetic acid (ketone body)
|
0.69 mg/dL
Standard Deviation 0.24
|
0.30 mg/dL
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedAs determined by HbA1C values
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Glycemic Control (HbA1C)
|
7.85 percentage of hemoglobin
Standard Deviation 1.66
|
8.26 percentage of hemoglobin
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatmentDetermined as weight in kg divided by height in meters squared
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
BMI
|
30.53 kg/m^2
Standard Error 1.29
|
34.64 kg/m^2
Standard Error 1.36
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatmentUsing ReeVue (trademark) machine, with or without SGLT2 inhibitor therapy to ascertain if Cana has any effect on RMR. Other related trials have shown weight loss but effect on metabolic rate has not been studied .
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Resting Metabolic Rate (RMR)
|
1999.31 kcal/day
Standard Error 67.45
|
1863.01 kcal/day
Standard Error 165.91
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)Vessel health assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR .
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Pulse Wave Velocity
|
10.12 m/s
Standard Deviation 0.63
|
11.42 m/s
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: measured at 8 and 16 (reported) weeks post treatmentHighly selective C-reactive protein (hs-CRP)
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Serum Endothelial Inflammatory Markers (2)
|
0.63 mg/L
Standard Deviation 0.2
|
0.92 mg/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedMeasured from blood glucose values (fasting) during visit
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Glycemic Control
|
142.79 mg/dL
Standard Deviation 45.24
|
158.0 mg/dL
Standard Deviation 38.4
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatmentMeasured using a Tanita body composition scale
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Body Fat Percentage
|
32.46 percentage of body mass
Standard Error 2.32
|
38.58 percentage of body mass
Standard Error 2.63
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)Vessel health assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR. Higher values generally correlate with increased cardiovascular risk.
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Augmentation Index (Pulse Wave Analysis)
|
28.67 percent aug pressure of pulse pressure
Standard Deviation 2.8
|
21.37 percent aug pressure of pulse pressure
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedCreatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Kidney Function Markers
PODXL
|
6.62 ug/dL
Standard Error 0.30
|
6.68 ug/dL
Standard Error 0.4
|
|
Kidney Function Markers
Nephrin
|
5.24 ug/dL
Standard Error 0.50
|
5.87 ug/dL
Standard Error 0.65
|
|
Kidney Function Markers
Wilm's Tumor
|
5.75 ug/dL
Standard Error 0.59
|
6.36 ug/dL
Standard Error 0.75
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedCreatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Creatinine (Urine)
|
77.08 mmol/L
Standard Error 15.58
|
106.23 mmol/L
Standard Error 15.62
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedCreatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
Microalbumin
|
33.97 mg/g creatinine
Standard Error 13.24
|
43.41 mg/g creatinine
Standard Error 26.17
|
SECONDARY outcome
Timeframe: 16 weeks post Canagliflozin treatment reportedCreatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests
Outcome measures
| Measure |
Active Arm
n=15 Participants
100 mg of Canagliflozin for 16 weeks
Canagliflozin: 100 mg
|
Placebo Arm
n=14 Participants
Placebo for 16 weeks
Placebo: 1 tablet daily for 16 weeks
|
|---|---|---|
|
eGFR
|
79.90 mL/min
Standard Error 4.21
|
88.33 mL/min
Standard Error 4.52
|
Adverse Events
Active Arm
Placebo Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sabyasachi Sen
George Washington University Medical Faculty Associates
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place