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Angiotensin Receptor-Neprilysin Inhibitor

LCZ 696 for Type 2 Diabetes

Phase 2
Recruiting
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
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I can walk more than 450 meters in 6 minutes, or less if due to hip/knee pain.
Select...
My heart pumps well and I've never had heart failure.
Select...
I have been on diabetes medication for at least 6 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma cGMP Response
Secondary outcome measures
Renal response

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
3,191 Previous Clinical Trials
3,758,431 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can older people participate in this research?

"This study is open to participants aged 18-85."

Answered by AI

Do people exhibit negative side effects from LCZ 696?

"LCZ 696's safety is based off of preclinical data and was given a score of 2."

Answered by AI

Which type of person is this research looking for?

"This clinical study is looking for 72 males and females, aged 18 to 85, that have type 2 diabetes mellitus. In addition to this broad inclusion criteria, participants must also meet the following specific conditions: 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, 60 male and female subjects >18years 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, Minimal distance of >450"

Answered by AI

Are participants currently being recruited for this research?

"No, this particular clinical trial is not presently recruiting patients. However, according to the data hosted on clinicaltrials.gov, it was last edited on 8/18/2022. There are many other clinical trials (874 in total) that are actively looking for patients right now."

Answered by AI

How many people are included in the experimental group for this clinical trial?

"This study has completed recruitment for participants. However, if you're looking for other research opportunities, 835 clinical trials are currently underway that focus on diabetes mellitus, type 2 and 39 studies are investigating the efficacy of LCZ 696."

Answered by AI

Can you give us some background on other similar research projects to LCZ 696?

"There are currently 8 Phase 3 trials and 39 total studies being conducted for LCZ 696. The majority of these research sites are located in Montreal, but there are a grand total of 812 locations running clinical trials for LCZ 696."

Answered by AI

What are LCZ 696's primary therapeutic benefits?

"Patients with uncontrolled hypertension and Ventricular Dysfunction can find relief with LCZ 696."

Answered by AI
~3 spots leftby Jun 2024