Trial Outcomes & Findings for Dapagliflozin Effects on Epicardial Fat (NCT NCT02235298)

NCT ID: NCT02235298

Last Updated: 2021-02-16

Results Overview

Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: At Baseline, 12 weeks, 24 weeks
• Results posted on: 2021-02-16

Participant Flow

Participant milestones

Measure	Dapagliflozin and Metformin Group Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL	Metformin and Placebo Group Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin
Overall Study STARTED	50	50
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Measure	Dapagliflozin and Metformin Group Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL	Metformin and Placebo Group Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin
Overall Study Lost to Follow-up	6	5
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Dapagliflozin Effects on Epicardial Fat

Baseline characteristics by cohort

Measure	Dapagliflozin and Metformin Group n=50 Participants Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL	Metformin and Placebo Group n=50 Participants Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin	Total n=100 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 9 • n=5 Participants	51 years STANDARD_DEVIATION 11 • n=7 Participants	51.5 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Baseline, 12 weeks, 24 weeks

Population: Data is reported only for the participants that completed the study intervention.

Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks

Outcome measures

Measure	Dapagliflozin and Metformin Group n=42 Participants Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL	Metformin and Placebo Group n=42 Participants Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin
Epicardial Fat Thickness Baseline	8.6 mm Standard Deviation 2.2	8.0 mm Standard Deviation 2.5
Epicardial Fat Thickness 12 Weeks	7.2 mm Standard Deviation 2.3	7.4 mm Standard Deviation 2.5
Epicardial Fat Thickness 24 Weeks	6.7 mm Standard Deviation 2.1	7.5 mm Standard Deviation 2.4

SECONDARY outcome

Timeframe: At Baseline, Week 12 and Week 24

Population: Due to time and technical limitations, LVM data were not collected for all participants that completed the study intervention.

LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24

Outcome measures

Measure	Dapagliflozin and Metformin Group n=33 Participants Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL	Metformin and Placebo Group n=24 Participants Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin
Left Ventricular Mass (LVM) Baseline	129 g/m^2 Standard Deviation 13	130 g/m^2 Standard Deviation 19
Left Ventricular Mass (LVM) Week 12	127 g/m^2 Standard Deviation 18	128 g/m^2 Standard Deviation 20
Left Ventricular Mass (LVM) Week 24	122 g/m^2 Standard Deviation 19	122 g/m^2 Standard Deviation 20

Adverse Events

Dapagliflozin and Metformin Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Metformin and Placebo Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dapagliflozin and Metformin Group n=50 participants at risk Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL	Metformin and Placebo Group n=50 participants at risk Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin
Renal and urinary disorders Urinary Tract Infection	2.0% 1/50 • Number of events 1 • 24 Weeks	0.00% 0/50 • 24 Weeks
Renal and urinary disorders Balanitis	2.0% 1/50 • Number of events 1 • 24 Weeks	0.00% 0/50 • 24 Weeks
Gastrointestinal disorders Diarrhea	0.00% 0/50 • 24 Weeks	4.0% 2/50 • Number of events 2 • 24 Weeks
Gastrointestinal disorders Abdominal Distention	0.00% 0/50 • 24 Weeks	4.0% 2/50 • Number of events 2 • 24 Weeks
Renal and urinary disorders Frequency of Urination	12.0% 6/50 • Number of events 6 • 24 Weeks	0.00% 0/50 • 24 Weeks
Renal and urinary disorders Dysuria	12.0% 6/50 • Number of events 6 • 24 Weeks	0.00% 0/50 • 24 Weeks

Additional Information

Gianluca Iacobellis, MD

University of Miami

Phone: 305-243-3636

Email: giacobellis@miami.edu

Results disclosure agreements

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