Trial Outcomes & Findings for Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus (NCT NCT03660683)
NCT ID: NCT03660683
Last Updated: 2023-06-05
Results Overview
Proportion of cells that migrate through SDF1a in a transwell assay. This proportion is represented as a migratory rating scale from 0-1, with 1 being 100% of cells migrate. A larger value indicates better migratory function of the CD34+ cells.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
Group A Dapa
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Blood Pressure
Systolic
|
104 mmHg
STANDARD_DEVIATION 5.7 • n=5 Participants
|
125 mmHg
STANDARD_DEVIATION 9.9 • n=7 Participants
|
138.8 mmHg
STANDARD_DEVIATION 18.0 • n=5 Participants
|
127.4 mmHg
STANDARD_DEVIATION 18.1 • n=4 Participants
|
|
Blood Pressure
Diastolic
|
69.5 mmHg
STANDARD_DEVIATION 0.7 • n=5 Participants
|
78 mmHg
STANDARD_DEVIATION 2.4 • n=7 Participants
|
82.5 mmHg
STANDARD_DEVIATION 13.5 • n=5 Participants
|
78.8 mmHg
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
CD34+ Cell Fraction
|
0.61 percentage of WBC
STANDARD_DEVIATION 0.77 • n=5 Participants
|
2.35 percentage of WBC
STANDARD_DEVIATION 1.79 • n=7 Participants
|
3.55 percentage of WBC
STANDARD_DEVIATION 1.74 • n=5 Participants
|
2.23 percentage of WBC
STANDARD_DEVIATION 1.78 • n=4 Participants
|
|
Colony Forming Units (Day 14)
|
18.9 cfu (integer)
STANDARD_DEVIATION 26.9 • n=5 Participants
|
12.6 cfu (integer)
STANDARD_DEVIATION 6.9 • n=7 Participants
|
9.7 cfu (integer)
STANDARD_DEVIATION 7.6 • n=5 Participants
|
13.4 cfu (integer)
STANDARD_DEVIATION 15.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksProportion of cells that migrate through SDF1a in a transwell assay. This proportion is represented as a migratory rating scale from 0-1, with 1 being 100% of cells migrate. A larger value indicates better migratory function of the CD34+ cells.
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
CD 34+ Cell Migratory Function
|
0.675 score on a scale
Standard Deviation 0.094
|
0.75 score on a scale
Standard Deviation 0.096
|
0.253 score on a scale
Standard Deviation 0.352
|
SECONDARY outcome
Timeframe: 16 weeks from visit 1Fold change of Gene Expression in T2Dm with CVD relative to visit 1
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
CD 34+ Cell Gene Expression
KDR
|
0.70 fold change
Standard Error 0.13
|
0.44 fold change
Standard Error 0
|
1.76 fold change
Standard Error 0.26
|
|
CD 34+ Cell Gene Expression
NOS3
|
1.63 fold change
Standard Error 0.40
|
4.16 fold change
Standard Error 0.88
|
0.99 fold change
Standard Error 0.11
|
|
CD 34+ Cell Gene Expression
CAT
|
2.57 fold change
Standard Error 0.52
|
7.12 fold change
Standard Error 2.14
|
1.71 fold change
Standard Error 0.28
|
|
CD 34+ Cell Gene Expression
CXCL12
|
6.83 fold change
Standard Error 2.87
|
4.23 fold change
Standard Error 0
|
2.34 fold change
Standard Error 0.44
|
|
CD 34+ Cell Gene Expression
CXCR4
|
1.71 fold change
Standard Error 0.27
|
0.56 fold change
Standard Error 0.07
|
1.08 fold change
Standard Error 0.08
|
|
CD 34+ Cell Gene Expression
EDN1
|
2.67 fold change
Standard Error 0.79
|
0.89 fold change
Standard Error 0.06
|
0.82 fold change
Standard Error 0.08
|
|
CD 34+ Cell Gene Expression
GAPDH
|
2.87 fold change
Standard Error 0.56
|
3.22 fold change
Standard Error 0.86
|
4.23 fold change
Standard Error 1.05
|
|
CD 34+ Cell Gene Expression
GPX3
|
0.89 fold change
Standard Error 0.14
|
0.65 fold change
Standard Error 0.09
|
3.37 fold change
Standard Error 0.29
|
|
CD 34+ Cell Gene Expression
IL6
|
1.08 fold change
Standard Error 0.18
|
0.17 fold change
Standard Error 0.02
|
2.97 fold change
Standard Error 0.48
|
|
CD 34+ Cell Gene Expression
P21
|
1.11 fold change
Standard Error 0.16
|
1.55 fold change
Standard Error 0.27
|
1.23 fold change
Standard Error 0.04
|
|
CD 34+ Cell Gene Expression
PECAM1
|
2.86 fold change
Standard Error 0.39
|
6.19 fold change
Standard Error 1.21
|
1.69 fold change
Standard Error 0.14
|
|
CD 34+ Cell Gene Expression
SOD2
|
1.96 fold change
Standard Error 0.23
|
2.23 fold change
Standard Error 0.41
|
2.19 fold change
Standard Error 0.37
|
|
CD 34+ Cell Gene Expression
TNF
|
1.76 fold change
Standard Error 0.22
|
0.79 fold change
Standard Error 0.14
|
1.12 fold change
Standard Error 0.10
|
|
CD 34+ Cell Gene Expression
TP53
|
2.41 fold change
Standard Error 0.63
|
3.53 fold change
Standard Error 1.07
|
1.55 fold change
Standard Error 0.21
|
|
CD 34+ Cell Gene Expression
VEGFA
|
1.41 fold change
Standard Error 0.19
|
6.14 fold change
Standard Error 2.05
|
1.29 fold change
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 16 weeksQuantifying CD34+ cells is based on proportion of the monocytes that are CD34+ to account for any variations in cell harvesting or death during analysis.
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
CD 34+ Cell Fraction
|
1.15 percentage of cells
Standard Error 0.33
|
3.17 percentage of cells
Standard Error 0.27
|
1.74 percentage of cells
Standard Error 0.31
|
SECONDARY outcome
Timeframe: 16 WeeksAugmentation index was calculated via tonometry with Sphygmocor Device (Pulse Wave Analysis). Augmentation index is calculated as the augmentation pressure (the amplitude of the reflected pulse wave) divided by the pulse pressure (systolic - diastolic) \* 100 to give a percentage of pulse pressure. The software then calculates an estimated Augmentation Index at heart rate of 75 as a form of "normalization." Lower values are generally preferred as they indicate more pliable and healthy arteries.
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Arterial Stiffness - Augmentation Index
Aug Index
|
13.67 percentage of pulse pressure
Standard Error 2.17
|
34 percentage of pulse pressure
Standard Error 2.83
|
25.65 percentage of pulse pressure
Standard Error 0.15
|
|
Arterial Stiffness - Augmentation Index
Aug Index @75 Heart Rate
|
12 percentage of pulse pressure
Standard Error 1
|
30 percentage of pulse pressure
Standard Error 3.96
|
27.75 percentage of pulse pressure
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 16 WeekshsCRP
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Blood Biochemistries
|
1.265 mg/L
Standard Deviation 0.975
|
1.408 mg/L
Standard Deviation 1.106
|
4.258 mg/L
Standard Deviation 1.799
|
SECONDARY outcome
Timeframe: 16 WeeksMicroalbumin/Creatinine Ratio (Proteinuria)
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Renal Function
|
37.3 mcg/mg
Standard Error 11.9
|
13.22 mcg/mg
Standard Error 0.96
|
158.48 mcg/mg
Standard Error 47.76
|
SECONDARY outcome
Timeframe: 16 WeeksProtein western analysis of Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health. Expressed as a ratio normalized to CD9 expression
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Urine Exosome Assay
Nephrin
|
1.16 ratio
Standard Error 0.10
|
0.49 ratio
Standard Error 0.10
|
0.67 ratio
Standard Error 0.13
|
|
Urine Exosome Assay
Podocalyxin
|
2.59 ratio
Standard Error 0.43
|
2.10 ratio
Standard Error 0.48
|
0.79 ratio
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Week 16Pulse Wave Velocity
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Arterial Stiffness
|
8.23 m/s
Standard Error 0.16
|
8.1 m/s
Standard Error 0.14
|
9.55 m/s
Standard Error 0.22
|
SECONDARY outcome
Timeframe: 16 WeeksAugmentation index was calculated via tonometry with Sphygmocor Device (Pulse Wave Analysis). Augmentation index is calculated as the augmentation pressure (the amplitude of the reflected pulse wave) divided by the pulse pressure (systolic - diastolic) \* 100 to give a percentage of pulse pressure. The software then calculates an estimated Augmentation Index at heart rate of 75 as a form of "normalization." Lower values are generally preferred as they indicate more pliable and healthy arteries. Here, augmentation pressure is shown as a reference for the Augmentation Index calculations in the previous section.
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Arterial Stiffness - Augmentation Pressure
|
4.0 mmHg
Standard Error 0.66
|
13.5 mmHg
Standard Error 1.55
|
6.77 mmHg
Standard Error 0.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 WeeksTotal Cholesterol, LDL, HDL and VLDL
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Fasting Lipid Profile
Total Cholesterol
|
155.5 mg/dL
Standard Error 7.2
|
119.8 mg/dL
Standard Error 3.1
|
149.4 mg/dL
Standard Error 5.6
|
|
Fasting Lipid Profile
HDL
|
41.5 mg/dL
Standard Error 1.2
|
37.8 mg/dL
Standard Error 2.5
|
40.8 mg/dL
Standard Error 1.4
|
|
Fasting Lipid Profile
VLDL
|
20.0 mg/dL
Standard Error 1.4
|
30.8 mg/dL
Standard Error 4.4
|
25.4 mg/dL
Standard Error 2.5
|
|
Fasting Lipid Profile
LDL
|
94.0 mg/dL
Standard Error 0.7
|
51.2 mg/dL
Standard Error 3.1
|
83.2 mg/dL
Standard Error 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 WeeksMeasured in fasting state at visit
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Serum Insulin Level
|
15.5 mcU/mL
Standard Error 2.3
|
15.8 mcU/mL
Standard Error 1.9
|
20.2 mcU/mL
Standard Error 2.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 WeeksFasting Glucose level measured in serum
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Serum Glucose
|
113.5 mg/dL
Standard Deviation 13.5
|
106.4 mg/dL
Standard Deviation 24.3
|
184.8 mg/dL
Standard Deviation 41.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 WeeksLeptin, (Adiponectin, GLP1, Ghrelin in separate entry)
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Appetite Controlling Hormone
|
8.13 ng/mL
Standard Deviation 3.83
|
25.60 ng/mL
Standard Deviation 15.64
|
80.96 ng/mL
Standard Deviation 55.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 WeeksHbA1C (estimate of serum glucose over 3 months)
Outcome measures
| Measure |
Group A Dapa
n=4 Participants
Dapagliflozin 10 mg + Saxagliptin Placebo
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
|
Group B DapaSaxa
n=5 Participants
Dapagliflozin 10mg + Saxagliptin 5mg
Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Saxagliptin 5mg: Saxagliptin 5 mg PO QD
|
Placebo
n=6 Participants
Placebo Oral Tablet
Placebo Oral Tablet: Matching Placebo Tablets
|
|---|---|---|---|
|
Serum Glucose
|
8.53 percentage of hemoglobin
Standard Deviation 3.16
|
2.43 percentage of hemoglobin
Standard Deviation 1.62
|
8.80 percentage of hemoglobin
Standard Deviation 1.47
|
Adverse Events
Group A Dapa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B DapaSaxa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Phone: 301-461-6676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place