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New treatment option for Type 2 Diabetes Mellitus in Obese
Official title Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
ClinicalTrials.gov ID: NCT05838287
What this study is testing
What is Pioglitazone?
Pioglitazone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type 2 diabetes mellitus in obese.
Also referred to as Actos.
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
- Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are: 1.
- Phase 4: studies an already-approved treatment
- 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 70. Healthy volunteers may be eligible.
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 30-70 years
- Body Mass Index (BMI) of 27.5-40kg/m²
- HbA1c of 6.5 to 10%
You likely can't join if
- people with history of osteoporosis or proliferative diabetic retinopathy
- people with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart...
- Patients with symptomatic coronary artery disease.
- people with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of...
- people treated with a GLP-1 RA or thiazolidinedione.
- people treated with a SGLT2i
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 30-70 years
- Body Mass Index (BMI) of 27.5-40kg/m²
- HbA1c of 6.5 to 10%
- Blood pressure of less than or equal to 145/65mmHg
- eGFR greater than 45 ml/min/1.73m²
- Subject must have HFpEF (EF \> 50% by ECHO screening)
- NYHA class II-III heart failure
- Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional [4 weeks] after...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- people with history of osteoporosis or proliferative diabetic retinopathy
- people with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded
- Patients with symptomatic coronary artery disease.
- people with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another HF medication).
- people treated with a GLP-1 RA or thiazolidinedione.
- people treated with a SGLT2i
- Pregnancy or lactation
- Known allergic reactions to components of the study interventions.
- Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker
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 70 years. Healthy volunteers may be eligible. 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.