Taking people in United StatesPhase 1

Tests empagliflozin with pioglitazone in people with type 2 diabetes

Tests whether pioglitazone changes ketone production caused by empagliflozin 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: NCT07053319
Registry title: SGLT2i, Pioglitazone, and Ketone Production in T2D
Status: Recruiting
Phase: Phase 1
People taking part: 64 people, planned
Started: 11 May 2026
Expected to end: 30 Jun 2027
Type of study: Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Empagliflozin 25 MG
Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo
Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)
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 aged 30-75 with type 2 diabetes, in general good health, treated with diet, sulfonylureas, metformin, or a stable GLP1-RA or DPP-4 inhibitor.

Age: 30 to 75 years
Sex: All sexes can join.
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 both. GLP1-RA needs a stable dose for at least 3 months; DPP-4 inhibitor for at least 2 months. SGLT2 inhibitors must be stopped at least 2 months before. Statins are allowed if the dose was stable for 3 months.

Main reasons for not taking part

Treatment with thiazolidinediones (TZDs) or insulin
Other medicines that affect glucose metabolism
Proliferative retinopathy or eGFR below 60
Women who can become pregnant, unless using appropriate contraception
Taking an SGLT2 inhibitor within 2 months of screening

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
Statin therapy is permissible if the dose has been stable for at least 3 months

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:

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

To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).

The 3 groups in the trial

Empagliflozin plus Pioglitazone placeboTreatment being tested
Empagliflozin 25 mg/day
Treatment: Empagliflozin 25 MG
Pioglitazone plus Empagliflozin PlaceboPlacebo, for comparison
Pioglitazone, 15 mg/day, increased to 30 mg after 2 weeks
Treatment: Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo
Empagliflozin plus PioglitazoneTreatment being tested
Empagliflozin(25mg/day) plus pioglitazone (15/30 mg/d)
Treatment: Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)