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Effect of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers

NCT02724566 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-12-10

No results posted yet for this study

Summary

Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.

Conditions

Interventions

DRUG

apelin

Assessing the difference between the insulin sensitivity measured during hyperinsulinemic euglycemic clamps in the presence of a 2 hours continuous infusion of (PYR1)-apelin-13 (30nmol/kg) versus a 2 hours continuous infusion of placebo (vehicle alone).

DRUG

placebo

2 hours continuous infusion of placebo (vehicle alone) to compare with 2 hours infusion of apelin

Sponsors & Collaborators

  • Société Francophone du Diabète

    collaborator OTHER

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Pierre Gourdy, PhD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02724566 on ClinicalTrials.gov