Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes (NEPT2D)

May 4, 2021 updated by: Nicolai Jacob Wewer Albrechtsen, University of Copenhagen

The Effect of Neprilysin on Plasma Concentrations of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • RegionH
      • Hvidovre, RegionH, Denmark, 2650
        • Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants are subjected to a standardized meal
Drug: Placebo
placebo day
Active Comparator: Entrestro
194 mg sacubitril / 206 mg valstartan (entresto) as one single dose followed by a standardized meal
Drug: Entresto
Single dose administration of entresto
Active Comparator: Sitagliptin
200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
Drug: Sitagliptin
Single dose administration of sitagliptin
Active Comparator: 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
Drug: Entresto
Single dose administration of entresto
Drug: Sitagliptin
Single dose administration of sitagliptin
Active Comparator: Valsartan
206mg valsartan as one single dose followed by a standardized meal
Drug: Valsartan
single doses administration of valsartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose
Time Frame: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of glucose
3 hours after treatment ( during the subsequent standardized meal)

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Concentrations of GLP-1
Time Frame: 3 hours after treatment ( during the subsequent standardized meal)
3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of GIP
Time Frame: 3 hours after treatment ( during the subsequent standardized meal)
3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Glucagon
Time Frame: 3 hours after treatment ( during the subsequent standardized meal)
3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Insulin
Time Frame: 3 hours after treatment ( during the subsequent standardized meal)
3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of C-Peptide
Time Frame: 3 hours after treatment ( during the subsequent standardized meal)
3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Amino Acids
Time Frame: 3 hours after treatment ( during the subsequent standardized meal)
3 hours after treatment ( during the subsequent standardized meal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEPT2D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type2 Diabetes

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe