NCT03717688

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started May 2018

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

September 20, 2018

Last Update Submit

July 3, 2019

Conditions

DiabetesHeart Failure

Keywords

GLP-1NeprilysinDPP-4

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • C-peptide

    3 hours after treatment ( during the subsequent standardized meal)

  • Glucagon

    3 hours after treatment ( during the subsequent standardized meal)

Other Outcomes (2)

  • Blood glucose

    3 hours after treatment and during the subsequent standardized meal

  • GIP

    3 hours after treatment ( during the subsequent standardized meal)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

No treatment. Participants are subjected to a standardized meal

Drug: Placebos

Entrestro as single dose

ACTIVE COMPARATOR

194 mg sacubitril / 206 mg valstartan (entresto) as one single dose followed by a standardized meal

Drug: Entresto

Sitagliptin as single dose

ACTIVE COMPARATOR

200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal

Drug: Sitagliptin 100mg

Entrestro + sitagliptin as single dose

ACTIVE COMPARATOR

194 mg sacubitril / 206 mg valstartan (entresto) + 200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal

Drug: EntrestoDrug: Sitagliptin 100mg

Interventions

EntrestoDRUG

Single dose administration of Entrestro 194 mg sacubitril / 206 mg valstartan

Also known as: ARNI, Neprilysin inhibibitor
Entrestro + sitagliptin as single doseEntrestro as single dose
Sitagliptin 100mgDRUG

2 x 100mg sitagliptin as single dose.

Also known as: DPP-4 inhibitor
Entrestro + sitagliptin as single doseSitagliptin as single dose
PlacebosDRUG

No treatment

Also known as: placebo
Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men
  • body mass index between 20-25

You may not qualify if:

  • acute diseases within the two weeks
  • chronic diseases
  • smoker
  • alcoholism, drug addiction or recent weight loss
  • blood donation within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Wewer Albrechtsen NJ, Mark PD, Terzic D, Hansen LH, Andersen UO, 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 Sitagliptin in Men. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3868-3876. doi: 10.1210/jc.2019-00515.

    PMID: 31074791RESULT

  • Thonsgaard S, Prickett TCR, Hansen LH, Wewer Albrechtsen NJ, Andersen UO, Terzic D, Plomgaard P, Gustafsson F, Goetze JP, Mark PD. Circulating Concentrations of C-Type Natriuretic Peptides Increase with Sacubitril/Valsartan Treatment in Healthy Young Men. Clin Chem. 2022 May 18;68(5):713-720. doi: 10.1093/clinchem/hvac005.

    PMID: 35175317DERIVED

MeSH Terms

Conditions

Diabetes MellitusHeart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combinationSitagliptin PhosphateDipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The participants are on 4 study days with wash out period of minimum 2 weeks randomized to 4 intervention arms
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Junior Consultant

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 24, 2018

Study Start

May 17, 2018

Primary Completion

February 1, 2019

Study Completion

May 14, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

DK(1)