LCZ 696 for Type 2 Diabetes

Overseen By Lynn Harstad

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Oral hypoglycemics, Insulin

Must not be taking: Loop diuretics

Disqualifiers: Heart failure, Myocardial infarction, Stroke, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Horng H Chen

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have type 2 diabetes.

I can walk more than 450 meters in 6 minutes, or less if due to hip/knee pain.

My heart pumps well and I've never had heart failure.

Exclusion Criteria

In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reason

Your HbA1C level is higher than 9% when you join the study.

Your blood sodium levels are very low (< 125 mEq/dL) or very high (> 160 mEq/dL).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Consent and Initial Assessment

Participants meet with study coordinator to review consent form, perform a 6-minute walk, receive diet instructions, and undergo initial lab tests and physical exam.

1 day

1 visit (in-person)

Treatment Phase 1

Participants undergo baseline assessments, receive either oral placebo or ARNI, and undergo saline infusion with repeated clearances and monitoring.

1 day

1 visit (in-person)

Washout and Crossover

Participants undergo a washout period before the crossover study.

1 week

Treatment Phase 2

Participants undergo the same procedures as Treatment Phase 1, receiving the alternate medication.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

Treatment Details

Interventions

• LCZ 696
• Placebos

Trial Overview 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.

Participant Groups

Group I: LCZ 696 Active Control 2 Interventions

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

Group II: Placebos Placebo Group 1 Intervention

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

LCZ 696 is already approved in United States, European Union for the following indications:

Approved in United States as Entresto for:

• Heart failure with reduced ejection fraction (NYHA Class II-IV)

Approved in European Union as Entresto for:

• Heart failure with reduced ejection fraction (NYHA Class II-IV)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+