The Effects of Neprilysin on Glucagon-like Peptide-1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2019-05-14

Brief Summary

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

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Detailed Description

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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

Conditions

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Diabetes Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The participants are on 4 study days with wash out period of minimum 2 weeks randomized to 4 intervention arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

No treatment. Participants are subjected to a standardized meal

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

No treatment

Entrestro as single dose

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

Group Type ACTIVE_COMPARATOR

Entresto

Intervention Type DRUG

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

Sitagliptin as single dose

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

Group Type ACTIVE_COMPARATOR

Sitagliptin 100mg

Intervention Type DRUG

2 x 100mg sitagliptin as single dose.

Entrestro + sitagliptin as single dose

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

Group Type ACTIVE_COMPARATOR

Entresto

Intervention Type DRUG

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

Sitagliptin 100mg

Intervention Type DRUG

2 x 100mg sitagliptin as single dose.

Interventions

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Entresto

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

Intervention Type DRUG

Sitagliptin 100mg

2 x 100mg sitagliptin as single dose.

Intervention Type DRUG

Placebos

No treatment

Intervention Type DRUG

Other Intervention Names

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ARNI Neprilysin inhibibitor DPP-4 inhibitor placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes