The Effects of Neprilysin on Glucagon-like Peptide-1

Heart Failure Clinical Trial

— NEP  

Official title:

The Effects of Neprilysin on Glucagon-like Peptide-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717688
• Other study ID #: NEP and GLP-1
• Status: Completed
• Phase: Phase 4
• Start date: May 17, 2018
• Est. completion date: May 14, 2019

Study information

• Verified date: July 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the current study we wish to investigate the effects on glucagon-like peptide-1 (GLP-1) of a neprilysin inhibitor

Description:

Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans is unknown. We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or place, to nine healthy men during a standardized meal and measured plasma concentrations of GLP-1

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 14, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• men

• body mass index between 20-25

Exclusion Criteria:

• acute diseases within the two weeks

• chronic diseases

• smoker

• alcoholism, drug addiction or recent weight loss

• blood donation within the last 3 months

Related Conditions & MeSH terms

• Diabetes
• Heart Failure

Intervention

Drug:
• Entresto
Single dose administration of Entrestro 194 mg sacubitril / 206 mg valstartan
• Sitagliptin 100mg
2 x 100mg sitagliptin as single dose.
• Placebos
No treatment

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Nicolai Jacob Wewer Albrechtsen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Wewer Albrechtsen NJ, Mark PD, Terzic D, Hansen LH, Andersen UØ, Hartmann B, Carr RD, Gustafsson F, Deacon CF, Holst JJ, Goetze JP, Plomgaard P. Sacubitril/valsartan augments postprandial plasma concentrations of active GLP-1 when combined with sitaglipti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood glucose	changes in blood glucose using immunological methods	3 hours after treatment and during the subsequent standardized meal
Other	GIP	changes in plasma GIP using immunological methods	3 hours after treatment ( during the subsequent standardized meal)
Primary	GLP-1	changes in plasma GLP-1 using immunological methods: intact and total GLP-1	3 hours after treatment ( during the subsequent standardized meal)
Secondary	C-peptide	changes in C-peptide using immunological methods	3 hours after treatment ( during the subsequent standardized meal)
Secondary	Glucagon	Changes in Plasma glucagon concentrations using different analytical methodologies	3 hours after treatment ( during the subsequent standardized meal)