Tests empagliflozin's effects on blood sugar and nerve signals in type 2 diabetes
Tests empagliflozin, with or without propranolol, in adults with type 2 diabetes.
Key facts
- Who runs it
- The University of Texas Health Science Center at San Antonio
- Where
- San Antonio, United StatesSee the site
- Trial code
- Registry title
- SGLT2i, Hepatic Glucose Production, and SNS
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 22 people, planned
- Started
- 7 Jan 2025
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional
- Treatments tested
- Empagliflozin 25 MG
- Record updated
- 17 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes who are in good general health. They must be treated with diet, sulfonylureas or metformin, and may also use a stable GLP-1 drug or DPP-4 inhibitor.
- Age
- 30 to 75 years
- Sex
- All sexes
- Disease stage
- Type 2 diabetes with HbA1c 7.0-11% (53–97 mmol/mol), BMI 21-45 kg/m2, eGFR above 60 ml/min/1.73m2, blood pressure 160/90 mmHg or lower.
- Earlier treatment
- Treated with diet, sulfonylureas, metformin, or sulfonylureas plus metformin. A GLP1-RA must be at a stable dose for at least three months, and a DPP-4 inhibitor for at least two months. SGLT2 inhibitors must be stopped at least two months before enrollment.
Main reasons for not taking part
- Treatment with thiazolidinediones (TZDs) or insulin
- Other medicines known to affect glucose metabolism
- Proliferative retinopathy or eGFR below 60
- Women who can become pregnant and do not use appropriate contraception
- Taking an SGLT2 inhibitor within 2 months of the screening visit
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Ages 30-75
- BMI (Body Mass Index) 21-45 kg/m2
- HbA1c = 7.0-11%
- eGFR (estimated glomerular filtration rate)> 60 ml/min/1.73m2
- Blood Pressure (BP)≤160/90 mmHg
- Participants must be in general good health based on medical history, physical exam, screening blood chemistries, CBC (Complete Blood Count), TSH/T4 (thyroid/thyroxine hormone), EKG (electrocardiogram), and urinalysis (UA)
- Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program
- Patients treated with diet, Sulfonylureas, Metformin, or Sulfonylureas/Metformin (Sulfo/MET)
- Participants receiving a Glucagon like peptide -1 receptor agonist (GLP1-RA) must be on a stable dose for at least three months prior to study enrollment
- Participants receiving a Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitor) must be on a stable dose for at least two months prior to study enrollment
- SGLT2 inhibitors must be discontinued at least two months prior to study enrollment
Who cannot take part
- Patients treated with Thiazolidinediones (TZDs), or Insulin are excluded
- Patients taking medications other than Sulfonylureas/Metformin (SU/MET), stable dose of GLP1-RA and DPP4i known to affect glucose metabolism are excluded. Patients taking SGLT2i within 2 months of screening visit will be excluded from participating in this study, however they may be asked whether they would agree to discontinue the medication for two months to become eligible. (Please see clarification below.) *
- Subjects with evidence of proliferative retinopathy or estimated glomerular filtration rate (eGFR) < 60 are excluded
- Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices * Only participants who are taking SGLT2 inhibitors during the prescreening period will be asked to discontinue the medication at least two months prior to the screening visit. If they agree, they will return for an HbA1c measurement four weeks after stopping the SGLT2 inhibitor; If their HbA1c rises to greater than 10%, treatment will be initiated with either metformin, a DPP-4 inhibitor, or a sulfonylurea. We do not anticipate any adverse effects during this initial period, provided the HbA1c remains below 10%; HbA1c will be measured using a fingerstick test, which requires only a minimal amount of blood. No compensation will be provided during this phase; After two months of medication discontinuation, participants will return for a screening visit. If they meet all eligibility criteria, they will be enrolled in the study and payment done by protocol
- An individual who meets any of the following criteria will be excluded from participation in this study:
Other criteria
- Patients with T2D
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Where in United States
- Texas Diabetes Institute/UHSan Antonio, United StatesContact: Ralph DeFronzo, MDTaking people
About the trial
What the trial wants to find out
In this study, PI will test the hypothesis that distinct mechanisms account for the SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic) glucose production in patients with type 2 diabetes (T2D) that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. Principal Investigator (PI) will conduct five distinct experiments to test this hypothesis in patients with T2D.
Read full original descriptionShow less
To examine the role of the SNS on the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D by comparing the effect of empagliflozin versus empagliflozin plus propranolol.
The group in the trial
- EmpagliflozinTreatment being tested
Empagliflozin 25 mg/day
Treatment: Empagliflozin 25 MG
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Protocol II: SGLT2i, Hepatic Glucose Production, and Sympathetic Nervous System (SNS)
- Plain-language title
- Tests empagliflozin's effects on blood sugar and nerve signals in type 2 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07053293, who can take part
- Record updated
- 17 July 2026