Trials / Suspended
SuspendedNCT03508739
Glucagon-like Peptide-1 Metabolism and Acute Neprilysin Inhibition
Glucagon-like Peptide-1 Metabolism in the Setting of Acute Neprilysin Inhibition
- Status
- Suspended
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Type 2 diabetes is common, increases in prevalence with age, and patients with diabetes have an increased risk of cardiovascular disease. A relatively new cardiovascular medication currently used for the treatment of heart failure in the United States inhibits an enzyme that breaks down a variety of signaling hormones. This clinical trial tests if it may also be a target for the treatment of diabetes by decreasing the breakdown of a hormone that increases insulin release after a meal.
Detailed description
This study will test the hypothesis that neprilysin inhibition with sacubitril/valsartan will increase endogenous glucagon-like peptide-1 (GLP-1) after a mixed meal compared to valsartan. The primary statistical analysis will be within subject comparison (paired t-test or nonparametric equivalent) of area under the curve intact GLP-1 after the meal during sacubitril/valsartan compared to valsartan. Neprilysin inhibition may be a new drug target for the treatment of type 2 diabetes by increasing intact GLP-1 and may be of particular benefit to individuals with increased risk of hypoglycemia and cardiovascular disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sacubitril/Valsartan 200mg (blinded) | study day 2 for AB and study day 3 for BA |
| DRUG | Valsartan 160mg (blinded) | study day 3 for AB and study day 2 for BA |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-30
- First posted
- 2018-04-26
- Last updated
- 2025-09-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03508739. Inclusion in this directory is not an endorsement.