NCT02747472

Brief Summary

Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

April 19, 2016

Last Update Submit

April 25, 2017

Conditions

Glucose Metabolism

Keywords

GIPGIP receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • Insulin levels

    Serum-insulin AUC (area under the curve for hyperglycemic clamp period)

    65 minutes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Infusion of saline

Other: Saline

GIP(1-42)

ACTIVE COMPARATOR

Infusion of agonist, GIP(1-42)

Drug: GIP(1-42)

GIP-A

EXPERIMENTAL

Infusion of GIP-A alone

Drug: GIP-A

GIP-A + GIP(1-42)

EXPERIMENTAL

Infusion of GIP-A and GIP(1-42)

Drug: GIP-ADrug: GIP(1-42)

Interventions

GIP-ADRUG

GIP receptor antagonist

GIP-AGIP-A + GIP(1-42)
GIP(1-42)DRUG

GIP receptor agonist

GIP(1-42)GIP-A + GIP(1-42)
SalineOTHER

Placebo

Placebo

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal kidney function, liver function and hemoglobin levels.

You may not qualify if:

  • Medication, Diabetes type 1 or 2, BMI \> 25, first degree relatives with Type 2 Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research

Copenhagen, Gentofte, 2900, Denmark

Location

Related Publications (1)

  • Gasbjerg LS, Christensen MB, Hartmann B, Lanng AR, Sparre-Ulrich AH, Gabe MBN, Dela F, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. GIP(3-30)NH2 is an efficacious GIP receptor antagonist in humans: a randomised, double-blinded, placebo-controlled, crossover study. Diabetologia. 2018 Feb;61(2):413-423. doi: 10.1007/s00125-017-4447-4. Epub 2017 Sep 25.

    PMID: 28948296DERIVED

MeSH Terms

Interventions

gastric inhibitory polypeptide (1-42)Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Filip K Knop, MD, PhD

    UHGentofte, Center for Diabetes Research

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 21, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

DK(1)