PDD in Type 2 Diabetes w/wo Diastolic Dysfunction

NCT03744975 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 17-006589
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study will advance the investigator's knowledge of the integrated cardiorenal and humoral physiology in type 2 diabetic patients with and without pre-clinical diastolic dysfunction, and test a novel therapeutic strategy which may prevent a progression to symptomatic Stage C heart failure

Conditions

Diabetes Mellitus, Type 2; Diastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Plasma cGMP Response

  The change in plasma cGMP levels from baseline to after volume expansion DM with PDD versus non-PDD

  3 months

Secondary Outcomes (1)

• Renal response

  3months

Study Arms (2)

Placebos

PLACEBO COMPARATOR

Control Intervention will be 1 Placebo Capsule given orally, one time

Drug: Placebos

LCZ 696

ACTIVE COMPARATOR

1st Experimental Arm will be 1 capsule of LCZ 696 given orally, one time

Drug: LCZ 696; Drug: Placebos

Interventions

LCZ 696 DRUG

Participants will receive Oral LCZ 696 (Entresto 97/103 mg)

Also known as: Entresto®), ARNI

LCZ 696

Placebos DRUG

Participants will receive 1oral Placebo capsule

Also known as: Placebo capsule

LCZ 696; Placebos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 not fatigue or shortness of breath, then they will still qualify for the protocol.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Horng H Chen

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Placebo-controlled study comparing Oral Placebo with Oral LCZ 696 (Entresto)

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: November 19, 2018
• Study Start: May 1, 2018
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)