Empagliflozin and Hepatic Glucose Metabolism

NCT03193684 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: HSC20170214H2R01DK097554-06
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study is to examine the role of autonomic nervous system in the increase in hepatic glucose production in response to glucosuria caused by inhibition of renal glucose uptake

Conditions

Hepatic Glucose Metabolism

Outcome Measures

Primary Outcomes (1)

• Effect of Empagliflozin on Autonomic Nervous System

  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

  Baseline and 12 weeks

Secondary Outcomes (1)

• Hepatic Glucose Production

  Baseline and 12 weeks

Other Outcomes (1)

• Absolute Percentage Change From Baseline to 12 Weeks in Hepatic Fat Content

  Baseline and12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

empagliflozin 25 mg per day

Drug: Empagliflozin 25 MG

control

PLACEBO COMPARATOR

matching placebo 1 pill per day

Drug: Control

Interventions

Empagliflozin 25 MG DRUG

subjects will receive daily dose of 25mg of empagliflozin for 3 months

Treatment

Control DRUG

Placebo

Also known as: Placebo

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR\>60 ml/min healthy volunteers type 2 diabetes patients who otherwise healthy

You may not qualify if:

• eGFR \<60 T2DM patients on insulin, GLP-1 RA or SGLT2 treatment Major organ disease type 1 diabetes

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Diabetes Division, UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

empagliflozin

Results Point of Contact

• Title: Dr. Muhammad Abdul-Ghani
• Organization: UTHSCSA

abdulghani@uthscsa.edu

210 567 6691

Study Officials

• Muhammad Abdul-Ghani, MD, PhD

  Diabetes Division, UTHSCSA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the study is placebo controlled double blinded. randomization will be made by pharmacist and the randomization code will be kept in the pharmacy
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: subjects will receive in parallel a treatment with empagliflozin or placebo for 3 months hepatic glucose metabolism and norepinephrine turnover will be studied before and after treatment

Study Record Dates

• First Submitted: June 17, 2017
• First Posted: June 21, 2017
• Study Start: May 20, 2018
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2024
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)