Type 2 Diabetes study: Polypill
Official title Polypill for Prevention of Cardiomyopathy
ClinicalTrials.gov ID: NCT06143566
What this study is testing
What is Polypill?
This is an investigational combination capsule being studied to see if it helps people with type 2 diabetes who are at high risk for heart failure. It is designed to combine three different medicines into one capsule to make it easier to take them all at once.
Also referred to as Finerenone, Empagliflozin, Losartan.
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
- The study wants to see if a combined polypill is practical and if it helps participants take their medicines better and improves heart fitness (peak VO2).
- Who it's for
- Adults who have type 2 diabetes, high blood pressure, and are judged to be at high risk for heart failure.
- What's involved
- Participants will take a daily pill that contains empagliflozin, losartan, and finerenone, or the same medicines given separately, and will have study visits and tests to measure heart fitness and medication use.
- Time commitment
- The trial lasts about 6 months and includes regular study visits and testing during that time.
- Phase 2: a mid-size study of how well it works
- Which group you join is 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 18 to 100
You may be able to join if
- Patients with Type 2 DM
- History of chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) of 25 to 90 per minute per 1.73 m2 of body-surface area...
- With either a: High risk of HF as defined by High Watch-DM score (≥11) or Elevated natriuretic peptides or Diastolic dysfunction or left ventricular...
You likely can't join if
- eGFR \< 25
- Congestive heart failure
- Hyperkalemia \> 5.0
- Contraindication to any component of polypill
- Pregnancy
- Creatinine \>2.0mg/dL in men and \>1.8mg/dL in women
See the full eligibility criteria
- Patients with Type 2 DM
- History of chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) of 25 to 90 per minute per 1.73 m2 of body-surface area (stage 2 to 4 CKD) with a urinary albumin-to-creatinine ratio (with...
- With either a: High risk of HF as defined by High Watch-DM score (≥11) or Elevated natriuretic peptides or Diastolic dysfunction or left ventricular hypertrophy on echocardiography
- eGFR \< 25
- Congestive heart failure
- Hyperkalemia \> 5.0
- Contraindication to any component of polypill
- Pregnancy
- Creatinine \>2.0mg/dL in men and \>1.8mg/dL in women
- Inability to calculate WATCH-DM score
- Inability to undergo exercise testing
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, 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, but 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, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.