Recruiting
Phase 1
Phase 2

Polypill

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06143566

Conditions

Type 2 Diabetes

High Blood Pressure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Polypill

Combined prescription of the individual medications

Study Details

Brief summary:

This study will investigate the utility of a polypill-based strategy for patients with type 2 diabetes mellitus and high risk of heart failure (HF), as assessed via the WATCH-DM risk score. Polypill therapy will consist of empagliflozin 12.5 mg, losartan 25, 50 or 100 mg, and finerenone 10 mg daily. The study duration is 6 months, and participants will be randomized to either polypill therapy or simultaneous prescription of the individual drugs. The primary outcome is change in peak VO2 and adherence to usual care. The investigators hypothesize that the use of a polypill is feasible and improves medication adherence and peak VO2 as compared to those receiving usual care.

Conditions

Type 2 Diabetes

High Blood Pressure

Study ID

NCT06143566

Start date

Mar 11, 2024

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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 albumin measured in milligrams and creatinine measured in grams) of less than 5000
  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Polypill

Participants will take a polypill containing finerenone 10 mg, empagliflozin 12.5 mg, and losartan (25, 50 mg, or 100 mg) daily.

active comparator: Combined prescription of the individual medications

Participants will be initiated on an SGLT2i, ARB, or finerenone if they are not already on the medication class.

Interventions

Polypill

A combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.

Combined prescription of the individual medications

We will initiate participants on an ARB, SGLT2i, and Finerenone if they are not in the polypill arm.

Primary outcome measure

  • Oxygen uptake during peak exercise (Peak VO2) [ Time Frame: Baseline, 3-month, and 6-month ]

Central Contacts and Locations

Central contacts

Ambarish Pandey, MD, MSCS

214-645-2101ambarish.pandey@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Ambarish Pandey, MD

214-645-9762ambarish.pandey@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Type 2 Diabetes
  • Diabetic Cardiomyopathy
  • Hypertension
  • Polypill

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-08-04.