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New treatment option for Type 2 Diabetes
Official title SGLT2i, Pioglitazone, and Ketone Production in T2D
ClinicalTrials.gov ID: NCT07053319
What this study is testing
What is Empagliflozin 25 MG?
Empagliflozin 25 MG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for type 2 diabetes.
Also referred to as Empagliflozin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- people 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...
See the full eligibility 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...
- 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
- 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...
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.