Trial Outcomes & Findings for Empagliflozin and Hepatic Glucose Metabolism (NCT NCT03193684)

NCT ID: NCT03193684

Last Updated: 2024-08-28

Results Overview

autonomic activity will be measured with as NE turnover rate. Total-body NE turnover rate was measured with 3H-NE infusion. A prime (3.8 µCi)-continuous (0.38 µCi/min) infusion of 3H-NE was started and continued for 60 minutes. Arterialized blood samples were collected before the start and between the 40-60 minute time period after the start of 3H-NE infusion. Total body NE turnover rate was calculated as the 3H-NE infusion rate (dpm/min) divided by the steady state plasma 3H-NE specific activity (dpm/pg) after 30 minutes

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2024-08-28

Participant Flow

Participant milestones

Measure	Treatment empagliflozin 25 mg per day Empagliflozin 25 MG: subjects will receive daily dose of 25mg of empagliflozin for 3 months	Control matching placebo 1 pill per day Control: Placebo
Overall Study STARTED	36	36
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment n=36 Participants empagliflozin 25 mg per day Empagliflozin 25 MG: subjects will receive daily dose of 25mg of empagliflozin for 3 months	Control n=36 Participants matching placebo 1 pill per day Control: Placebo	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=72 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=36 Participants	36 Participants n=36 Participants	72 Participants n=72 Participants
Age, Categorical >=65 years	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=72 Participants
Age, Continuous	55 years STANDARD_DEVIATION 2 • n=36 Participants	46 years STANDARD_DEVIATION 2 • n=36 Participants	51 years STANDARD_DEVIATION 2 • n=72 Participants
Sex: Female, Male Female	18 Participants n=36 Participants	17 Participants n=36 Participants	35 Participants n=72 Participants
Sex: Female, Male Male	18 Participants n=36 Participants	19 Participants n=36 Participants	37 Participants n=72 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	36 participants n=36 Participants	36 participants n=36 Participants	72 participants n=72 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

autonomic activity will be measured with as NE turnover rate.

Total-body NE turnover rate was measured with 3H-NE infusion. A prime (3.8 µCi)-continuous (0.38 µCi/min) infusion of 3H-NE was started and continued for 60 minutes. Arterialized blood samples were collected before the start and between the 40-60 minute time period after the start of 3H-NE infusion. Total body NE turnover rate was calculated as the 3H-NE infusion rate (dpm/min) divided by the steady state plasma 3H-NE specific activity (dpm/pg) after 30 minutes

Outcome measures

Measure	Treatment n=36 Participants empagliflozin 25 mg per day Empagliflozin 25 MG: subjects will receive daily dose of 25mg of empagliflozin for 3 months	Control n=36 Participants matching placebo 1 pill per day Control: Placebo
Effect of Empagliflozin on Autonomic Nervous System Baseline NE Turnover	480 ng/min Standard Error 42	621 ng/min Standard Error 87
Effect of Empagliflozin on Autonomic Nervous System 12 weeks NE Turnover	355 ng/min Standard Error 52	635 ng/min Standard Error 99

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: one patient in treatment arm did not complete the study due to Covid-19.

HGP will be measured with tracer dilution technique

Outcome measures

Measure	Treatment n=24 Participants empagliflozin 25 mg per day Empagliflozin 25 MG: subjects will receive daily dose of 25mg of empagliflozin for 3 months	Control n=12 Participants matching placebo 1 pill per day Control: Placebo
Hepatic Glucose Production Baseline	2.57 mg/kg/min Standard Error 0.15	2.63 mg/kg/min Standard Error 0.16
Hepatic Glucose Production Week 12	3.15 mg/kg/min Standard Error 0.21	2.50 mg/kg/min Standard Error 0.15

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and12 weeks

Population: Thirty individuals with T2D and 27 without were randomly assigned to receive in double-blind fashion empagliflozin or matching placebo (2:1 ratio) for 12 weeks.

the effect of treatment on hepatic fat content will be measured with MRS.

Outcome measures

Measure	Treatment n=30 Participants empagliflozin 25 mg per day Empagliflozin 25 MG: subjects will receive daily dose of 25mg of empagliflozin for 3 months	Control n=27 Participants matching placebo 1 pill per day Control: Placebo
Absolute Percentage Change From Baseline to 12 Weeks in Hepatic Fat Content	-2.39 percentage of liver fat content Standard Error 0.79	0.91 percentage of liver fat content Standard Error 0.64

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

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	Treatment n=36 participants at risk empagliflozin 25 mg per day Empagliflozin 25 MG: subjects will receive daily dose of 25mg of empagliflozin for 3 months	Control n=36 participants at risk matching placebo 1 pill per day Control: Placebo
Reproductive system and breast disorders Vaginal yeast infection	5.6% 2/36 • Number of events 2 • 12 weeks	2.8% 1/36 • Number of events 1 • 12 weeks

Additional Information

Dr. Muhammad Abdul-Ghani

UTHSCSA

Phone: 210 567 6691

Email: abdulghani@uthscsa.edu

Results disclosure agreements

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