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NCT Number: NCT03893526

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

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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Key information

Conditions

Type2 Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre Hospital

Hvidovre, RegionH, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entresto

Drug

Single dose administration of entresto

Sitagliptin

Drug

Single dose administration of sitagliptin

valsartan

Drug

single doses administration of valsartan

Placebo

Drug

placebo day

Primary outcomes

  1. Blood Glucose

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

    Plasma Concentrations of glucose

Secondary outcomes

  1. Plasma Concentrations of GLP-1

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

  2. Plasma Concentrations of GIP

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

  3. Plasma Concentrations of Glucagon

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

  4. Plasma Concentrations of Insulin

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

  5. Plasma Concentrations of C-Peptide

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

  6. Plasma Concentrations of Amino Acids

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

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

Acronym: NEPT2D

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 28, 2019
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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