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

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2021-03-01

Brief Summary

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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 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

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Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

Participants are subjected to a standardized meal

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo day

Entrestro

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 entresto

Sitagliptin

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

Intervention Type DRUG

Single dose administration of sitagliptin

Entrestro + sitagliptin

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 entresto

Sitagliptin

Intervention Type DRUG

Single dose administration of sitagliptin

Valsartan

206mg valsartan as one single dose followed by a standardized meal

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

single doses administration of valsartan

Interventions

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Entresto

Single dose administration of entresto

Intervention Type DRUG

Sitagliptin

Single dose administration of sitagliptin

Intervention Type DRUG

Valsartan

single doses administration of valsartan

Intervention Type DRUG

Placebo

placebo day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No