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Sacubitril-Valsartan for Prediabetes

Phase 4
Waitlist Available
Led By Joshua J Joseph, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Abnormal renal function tests: Glomerular Filtration Rate calculated using the Chronic Kidney Disease Epidemiology Equation < 60 ml/min/1.73 m²
History of, or planned, bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Approved for 10 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved

Summary

This trial is testing whether two drugs, valsartan and sacubitril, can improve blood sugar and insulin secretion better than valsartan alone in African Americans with impaired glucose tolerance.

Who is the study for?
This trial is for African Americans aged 18-65 with prediabetes or risk factors like a family history of type 2 diabetes. It's not for those with type 2 diabetes, recent significant weight loss, certain heart conditions, abnormal kidney function, severe psychiatric disorders, pregnancy or specific medication use.
What is being tested?
The study tests the effects of RAAS blockade (Valsartan) and combined RAAS/neprilysin inhibition (Sacubitril-Valsartan) versus placebo on blood sugar control and insulin release in African Americans with impaired glucose tolerance over a period of 26 weeks.
What are the potential side effects?
Possible side effects include dizziness due to low blood pressure, high potassium levels which can affect heart rhythm, kidney problems that may alter how the body cleans the blood, and allergic reactions if sensitive to the drugs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is below normal levels.
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I have had, or plan to have, weight loss surgery.
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I have been diagnosed with Type 2 Diabetes.
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I have lost more than 5% of my weight in the last 6 months.
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I am not on antipsychotic medication and do not have a severe psychiatric disorder.
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I have high blood pressure or I am on medication for it.
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I am taking oral medication for diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Structure of beta Cell of islet
Secondary study objectives
Change in Central Aortic Pressure (mmHg) from Baseline to 26 weeks

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Sacubitril/ValsartanExperimental Treatment1 Intervention
Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks
Group II: ValsartanActive Control1 Intervention
Valsartan 160 mg twice daily for 26 weeks
Group III: PlaceboPlacebo Group1 Intervention
placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure)

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,372 Total Patients Enrolled
23 Trials studying Obesity
3,884 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,018 Total Patients Enrolled
469 Trials studying Obesity
589,924 Patients Enrolled for Obesity
Joshua J Joseph, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
2 Previous Clinical Trials
172 Total Patients Enrolled

Media Library

Placebo Oral Tablet Clinical Trial Eligibility Overview. Trial Name: NCT03938389 — Phase 4
Obesity Research Study Groups: Valsartan, Sacubitril/Valsartan, Placebo
Obesity Clinical Trial 2023: Placebo Oral Tablet Highlights & Side Effects. Trial Name: NCT03938389 — Phase 4
Placebo Oral Tablet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938389 — Phase 4
~16 spots leftby Dec 2025
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