Trial Outcomes & Findings for Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production (NCT NCT03852901)

NCT ID: NCT03852901

Last Updated: 2022-08-02

Results Overview

Change in serum β-hydroxybutyrate (BHB) after 14 days on empagliflozin, compared with baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2022-08-02

Participant Flow

Participant milestones

Measure	Single Arm The single group of the study (empagliflozin group) took empagliflozin 25mg/day for 14 days.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production

Baseline characteristics by cohort

Measure	Single Arm n=21 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Age, Continuous	62.14 years STANDARD_DEVIATION 6.91 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Change in serum β-hydroxybutyrate (BHB) after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=21 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in Serum β-hydroxybutyrate (BHB)	40.717 µM Standard Error 4.866

SECONDARY outcome

Timeframe: 14 days

Change in plasma glucose after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=21 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in Plasma Glucose	-.637 mg/dl Standard Error 1.051

SECONDARY outcome

Timeframe: 14 days

Change in serum non-esterified fatty acids (NEFAs) after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=21 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in Serum Non-esterified Fatty Acids (NEFAs)	.027 mEq/L Standard Error .009

SECONDARY outcome

Timeframe: 14 days

Change in plasma insulin after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=21 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in Plasma Insulin	-2.647 mIU/L Standard Error 1.329

SECONDARY outcome

Timeframe: 14 days

Change in serum Acetoacetate (AcAc) after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=21 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in Serum Acetoacetate (AcAc)	-5.573 µM Standard Error 1.853

SECONDARY outcome

Timeframe: 14 days

Change in 1H MRS β-hydroxybutyrate (BHB) after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=20 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in 1H MRS BHB	0.04 mmol/L Standard Error 0.03

SECONDARY outcome

Timeframe: 14 days

Change in 1H MRS glutamate (Glu) after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=20 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in 1H MRS Glutamate (Glu)	-0.23 mmol/L Standard Error 0.11

SECONDARY outcome

Timeframe: 14 days

Change in 1H MRS glutamine (Gln) after 14 days on empagliflozin, compared with baseline.

Outcome measures

Measure	Single Arm n=20 Participants The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Change in 1H MRS Glutamine (Gln)	-0.27 mmol/L Standard Error 0.12

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Arm n=21 participants at risk The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Renal and urinary disorders Mild creatinine elevation	4.8% 1/21 • Number of events 1 • 14 days

Additional Information

Josephine M. Egan, MD, Clinical Director

National Institute on Aging

Phone: 410-558-8414

Email: eganj@mail.nih.gov

Results disclosure agreements

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