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Angiotensin Receptor-Neprilysin Inhibitor

LCZ 696 for Type 2 Diabetes

Phase 2
Waitlist Available
Led By Horng H Chen
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 2 diabetes mellitus
On at least one oral hypoglycemic agent, or glucagon-like peptide analogue or insulin, for at least 6 months
Must not have
Significant (> moderate) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
Severe congenital heart diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial will help researchers learn more about how diabetes affects heart function and whether a new treatment can prevent heart failure in people with diabetes.

Who is the study for?
This trial is for adults with Type 2 diabetes who may or may not have early heart muscle dysfunction but no symptoms of heart failure. They must be on diabetes medication for at least 6 months and able to walk a certain distance. People with severe kidney issues, recent serious heart conditions, extreme blood levels (like potassium), or other health problems that could affect the study can't join.
What is being tested?
The study is testing LCZ 696, a drug that might prevent worsening of heart function in diabetics compared to a placebo (a dummy pill). Participants will either receive LCZ 696 or the placebo to see if it helps manage their condition without causing further complications.
What are the potential side effects?
LCZ 696 could potentially cause changes in blood pressure, kidney function, and electrolyte levels. It might also lead to dizziness or an increased risk of angioedema (swelling under the skin), especially in those with previous reactions to similar drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes.
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I have been on diabetes medication for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart valve issues, thickened heart muscles, or specific heart inflammations.
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I was born with a serious heart condition.
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I have not had a stroke or significant brain blood flow issues in the last 3 months.
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I am currently on water pills for my heart or kidneys.
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My kidney function is severely reduced.
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I am currently pregnant or breastfeeding.
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I have been diagnosed with or shown signs of heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Plasma cGMP Response
Secondary study objectives
Renal response

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LCZ 696Active Control2 Interventions
1st Experimental Arm will be 1 capsule of LCZ 696 given orally, one time
Group II: PlacebosPlacebo Group1 Intervention
Control Intervention will be 1 Placebo Capsule given orally, one time

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,065 Total Patients Enrolled
Horng H ChenPrincipal InvestigatorMayo Clinic

Media Library

LCZ 696 (Angiotensin Receptor-Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03744975 — Phase 2
Type 2 Diabetes Research Study Groups: LCZ 696, Placebos
Type 2 Diabetes Clinical Trial 2023: LCZ 696 Highlights & Side Effects. Trial Name: NCT03744975 — Phase 2
LCZ 696 (Angiotensin Receptor-Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03744975 — Phase 2
~1 spots leftby Dec 2024
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