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CompletedNCT02747472GA-1Updated Apr 27, 2017

GIP Receptor Antagonist Studies in Humans

An interventional study of GIP-A and GIP(1-42) in Glucose Metabolism, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
20 Years to 30 Years
Sex
Male
01

Study summary

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

Read the detailed description

Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.

The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C) GIP[1-42] + GIP-A, or D) saline (placebo).

02

Conditions studied

  • Glucose Metabolism

Keywords

  • GIP
  • GIP receptor antagonist
03

In context

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal kidney function, liver function and hemoglobin levels.

Exclusion criteria

Exclusion Criteria:

  • Medication, Diabetes type 1 or 2, BMI > 25, first degree relatives with Type 2 Diabetes
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Infusion of saline

    Other: Saline

  • Active comparator
    GIP(1-42)

    Infusion of agonist, GIP(1-42)

    Drug: GIP(1-42)

  • Experimental
    GIP-A

    Infusion of GIP-A alone

    Drug: GIP-A

  • Experimental
    GIP-A + GIP(1-42)

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

    Drug: GIP-A · Drug: GIP(1-42)

Interventions

  • DrugGIP-A

    GIP receptor antagonist

  • DrugGIP(1-42)

    GIP receptor agonist

  • OtherSaline

    Placebo

06

What researchers measure

Primary outcomes

  1. Insulin levels

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

    Time frame: 65 minutes

07

Study locations

1 site
  • Center for Diabetes Research
    Copenhagen, Gentofte 2900, Denmark
08

References and documents

Publications

  • 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. PubMed 28948296 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02747472
Lead sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
Responsible party
Lærke Smidt Gasbjerg (MD, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Apr 21, 2016
Start date
Apr 2016
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Apr 27, 2017

Study contacts

Filip K Knop, MD, PhD
study director · UHGentofte, Center for Diabetes Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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