Trial Outcomes & Findings for The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts. (NCT NCT04400760)
NCT ID: NCT04400760
Last Updated: 2023-11-07
Results Overview
Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
DAPA Tx
This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.
DAPA Tx: The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.
Baseline characteristics by cohort
| Measure |
DAPA Tx
n=27 Participants
This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.
DAPA Tx: The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.
|
|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
PRU
|
160.93 PRU
STANDARD_DEVIATION 1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 weeks) to Completion (2 weeks) after DapagliflozinPlatelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin
Outcome measures
| Measure |
DAPA Tx
n=27 Participants
This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.
DAPA Tx: The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.
|
|---|---|
|
Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx
|
160.93 PRU
Interval 129.28 to 192.57
|
Adverse Events
DAPA Tx
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. Naveen Seecheran
The University of the West Indies, St. Augustine
Phone: 18687537686
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place