Trial Outcomes & Findings for Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure (NCT NCT04071626)

NCT ID: NCT04071626

Last Updated: 2023-12-13

Results Overview

The difference in peak oxygen uptake as measured by peak VO2 (ml/kg/min) between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 9 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-12-13

Participant Flow

Participant milestones

Measure	Ertugliflozin Treatment Arm Ertugliflozin 5 mg tablet once a day for 12 weeks Ertugliflozin 5 mg: Ertugliflozin 5 mg once a day for 12 weeks	Placebo Placebo tablet once a day for 12 weeks Placebo oral tablet: Placebo oral tablet once a day for 12 weeks
Overall Study STARTED	5	4
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Ertugliflozin Treatment Arm Ertugliflozin 5 mg tablet once a day for 12 weeks Ertugliflozin 5 mg: Ertugliflozin 5 mg once a day for 12 weeks	Placebo Placebo tablet once a day for 12 weeks Placebo oral tablet: Placebo oral tablet once a day for 12 weeks
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure

Baseline characteristics by cohort

Measure	Ertugliflozin Treatment Arm n=5 Participants Ertugliflozin 5 mg tablet once a day for 12 weeks Ertugliflozin 5 mg: Ertugliflozin 5 mg once a day for 12 weeks	Placebo n=4 Participants Placebo tablet once a day for 12 weeks Placebo oral tablet: Placebo oral tablet once a day for 12 weeks	Total n=9 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
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

The difference in peak oxygen uptake as measured by peak VO2 (ml/kg/min) between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment

Outcome measures

Measure	Ertugliflozin Treatment Arm n=4 Participants Ertugliflozin 5 mg tablet once a day for 12 weeks Ertugliflozin 5 mg: Ertugliflozin 5 mg once a day for 12 weeks	Placebo n=2 Participants Placebo tablet once a day for 12 weeks Placebo oral tablet: Placebo oral tablet once a day for 12 weeks
Peak VO2, ml/kg/Min, as Measured by Metabolic Gas Exchange	-0.6 Peak VO2, ml/kg/min Standard Deviation 1.13	-0.1 Peak VO2, ml/kg/min Standard Deviation 1.23

SECONDARY outcome

Timeframe: 12 weeks

Population: Data not collected.

The difference in LV mass index (gm/m2) measured by cardiac MRI between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

The difference in serum ketone bodies (betahydroxybutyrate) levels between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment

Outcome measures

Measure	Ertugliflozin Treatment Arm n=4 Participants Ertugliflozin 5 mg tablet once a day for 12 weeks Ertugliflozin 5 mg: Ertugliflozin 5 mg once a day for 12 weeks	Placebo n=2 Participants Placebo tablet once a day for 12 weeks Placebo oral tablet: Placebo oral tablet once a day for 12 weeks
Serum Ketone Bodies (Betahydroxybutyrate)	-0.045 mmol/L Standard Deviation 0.078	-0.018 mmol/L Standard Deviation 0.028

Adverse Events

Ertugliflozin Treatment Arm

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. Trevor Jenkins

University Hospitals Cleveland Medical Center

Phone: (216)844-1229

Email: Trevor.Jenkins@UHhospitals.org

Results disclosure agreements

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