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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03893526
Acronym
NEPT2D
Enrollment
12
Registered
2019-03-28
Start date
2019-01-25
Completion date
2021-03-01
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Keywords

GLP-1, Neprilysin, Diabetes

Brief 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

Interventions

DRUGSitagliptin

Single dose administration of sitagliptin

DRUGValsartan

single doses administration of valsartan

DRUGPlacebo

placebo day

DRUGEntresto

Single dose administration of entresto

Sponsors

Hvidovre University Hospital
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Glucose3 hours after treatment ( during the subsequent standardized meal)Plasma Concentrations of glucose

Secondary

MeasureTime frame
Plasma Concentrations of GIP3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Glucagon3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of GLP-13 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of C-Peptide3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Amino Acids3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Insulin3 hours after treatment ( during the subsequent standardized meal)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026