NCT03770910

Brief Summary

Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

December 6, 2018

Last Update Submit

March 25, 2020

Conditions

Endocrine - Other

Keywords

GIPInsulin secretinIncretin hormone

Outcome Measures

Primary Outcomes (1)

  • Insulin secretion

    Insulin secretion rates (ISR) calculated from serum levels of C-peptide

    8 weeks

Study Arms (6)

Placebo+placebo

PLACEBO COMPARATOR

Saline infusions

Other: Saline

GIP+placebo

ACTIVE COMPARATOR

GIP(1-42), receptor agonist

Other: GIP receptor agonistOther: Saline

GIP+dose 1

EXPERIMENTAL

GIP(1-42) and lowest dose of GIP(3-30)NH2

Other: GIP receptor antagonistOther: GIP receptor agonist

GIP+dose 2

EXPERIMENTAL

GIP(1-42) and dose of GIP(3-30)NH2

Other: GIP receptor antagonistOther: GIP receptor agonist

GIP+dose 3

EXPERIMENTAL

GIP(1-42) and dose of GIP(3-30)NH2

Other: GIP receptor antagonistOther: GIP receptor agonist

GIP+dose4

EXPERIMENTAL

GIP(1-42) and highest dose of GIP(3-30)NH2

Other: GIP receptor antagonistOther: GIP receptor agonist

Interventions

GIP receptor antagonistOTHER

GIP receptor antagonist

GIP+dose 1GIP+dose 2GIP+dose 3GIP+dose4
GIP receptor agonistOTHER

GIP(1-42)

GIP+dose 1GIP+dose 2GIP+dose 3GIP+dose4GIP+placebo
SalineOTHER

Placebo (vehicle for infusions)

GIP+placeboPlacebo+placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • BMI 19-28 kg/m\*m
  • Stable body weight

You may not qualify if:

  • Diabetes
  • Anemia
  • First-degree relatives with diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Metabolic Physiology

Gentofte Municipality, Copenhagen, 2900, Denmark

Location

Clinical Metabolic Physiology

Copenhagen, Gentofte, 2900, Denmark

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 10, 2018

Study Start

December 6, 2018

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers unless data management agreements are signed.

Locations

DK(2)