Diabetes Drug's hidden risk: when low fluids and insulin spark dangerous ketones
NCT ID NCT07053306
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study investigates why SGLT2 inhibitors, a common diabetes medication, can sometimes lead to ketoacidosis—a dangerous buildup of acids in the blood. Researchers suspect it only happens when patients also have low blood volume and low insulin levels. Adults with type 2 diabetes will receive a single dose of empagliflozin, and scientists will measure how their bodies produce and break down ketones.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin (a diabetes medication that lowers blood sugar by increasing glucose excretion in urine)
- What this could lead to
- If confirmed, this could help predict and prevent ketoacidosis in people with type 2 diabetes taking SGLT2 inhibitors.
- What could go wrong
- This is a small, early-phase mechanistic study, not a treatment trial. Results may not apply to all patients or lead to immediate clinical changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patients with T2D Inclusion Criteria: * 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. * Statin therapy is permissible if the dose has been stable for at least 3 months EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Texas Diabetes Institute/UH
RECRUITINGSan Antonio, Texas, 78229-3900, United States
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