A Study of PDD in Type 2 Diabetes

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-006589
    NCT ID: NCT03744975
    Sponsor Protocol Number: 17-006589

About this study

The purpose of  this study is to learn more about if the medications,  Nesiritide and Entresto, could help the function of the heart and kidneys.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • 60 male and female subjects > 18 years of age.
  • Type 2 diabetes mellitus.
  • On at least one oral hypoglycemic agent, or glucagon-like peptide analogue or insulin, for at least 6 months.
  • EF > 50% without diastolic dysfunction or EF > 50% with grade 2 or more diastolic dysfunction, without prior diagnosis, or signs and symptoms, of heart failure.
  • Minimal distance of >450 meters on a 6-minute walk. If the subject is not able to walk 450 meters due to pain in hips and/or knees, and does not have fatigue or shortness of breath, then they will still qualify for the protocol.

Exclusion Criteria

  • Age < 18 years.
  • HbA1C > 9 % at enrollment.
  • Prior diagnosis, or signs and symptoms, of heart failure.
  • Currently taking a loop diuretic.
  • Myocardial infarction within 6 months of  Visit 2.
  • Unstable angina within 6 months of Visit 2.
  • Significant (> moderate) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.
  • Severe congenital heart diseases.
  • Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening.
  • Second or third degree heart block without a permanent cardiac pacemaker.
  • Stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion.
  • ALT > 2 times the upper limit of normal.
  • Serum sodium of  < 125 mEq/dL or > 160 mEq/dL.
  • Serum potassium of < 3.5 mEq/dL or > 5.9 mEq/dL.
  • Hemoglobin < 9 gm/dl.
  • EGFR < 30 ml/min (at screening).
  • Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data.
  • Received an investigational drug within 1 month prior to dosing.
  • Patients with an allergy to iodine.
  • Female subject who is pregnant or breastfeeding.
  • In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reason.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Horng Chen, M.D.

Open for enrollment

Contact information:

Lynn Harstad

7744838

lharstad@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20379675

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