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

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

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 Dapagliflozin

Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin

Outcome measures

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place