Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes

Type2 Diabetes Clinical Trial

— NEPT2D  

Official title:

The Effect of Neprilysin on Plasma Concentrations of Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893526
• Other study ID #: NEPT2D
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 with type 2 diabetes 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 placebo, to patients with type 2 diabetes during a standardized meal and measured plasma concentrations of GLP-1

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes

• Oral Antidiabetics Medicine Only

• Body Mass Index of 25-35

• Type 2 Diabetes

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 Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• Entresto
Single dose administration of entresto
• Sitagliptin
Single dose administration of sitagliptin
• Valsartan
single doses administration of valsartan
• Placebo
placebo day

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre	RegionH

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose	Plasma Concentrations of glucose	3 hours after treatment ( during the subsequent standardized meal)
Secondary	Plasma Concentrations of GLP-1		3 hours after treatment ( during the subsequent standardized meal)
Secondary	Plasma Concentrations of GIP		3 hours after treatment ( during the subsequent standardized meal)
Secondary	Plasma Concentrations of Glucagon		3 hours after treatment ( during the subsequent standardized meal)
Secondary	Plasma Concentrations of Insulin		3 hours after treatment ( during the subsequent standardized meal)
Secondary	Plasma Concentrations of C-Peptide		3 hours after treatment ( during the subsequent standardized meal)
Secondary	Plasma Concentrations of Amino Acids		3 hours after treatment ( during the subsequent standardized meal)