Trial Outcomes & Findings for Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes (NCT NCT05139914)

Results Overview

Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

14 weeks

Results posted on

2026-02-11

Participant Flow

4 participants were enrolled but 1 was ineligible after screening so that 3 were randomized.

Participant milestones

Participant milestones
Measure	Dapagliflozin Then Placebo Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks	Placebo Then Dapagliflozin Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks
Overall Study STARTED	1	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapagliflozin Then Placebo Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks	Placebo Then Dapagliflozin Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapagliflozin Then Placebo n=1 Participants Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks	Placebo Then Dapagliflozin n=2 Participants Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	1 Participants n=2 Participants	2 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	1 Participants n=2 Participants	1 Participants n=3 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	1 Participants n=2 Participants	2 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	1 Participants n=2 Participants	1 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	2 participants n=2 Participants	3 participants n=3 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: Data were not analyzed for either study arm as there was only one participant in each arm at 14 weeks.

Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 14 weeks

Population: Data were not analyzed for either study arm as there was only one participant in each arm at 14 weeks.

Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff

Outcome measures

Outcome data not reported

Adverse Events

Dapagliflozin Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Then Dapagliflozin

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

Naomi Hamburg, MD

BU School of Medicine, Cardiovascular Medicine

Phone: (617) 638-7260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place