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CompletedNCT03702660GA-7Updated Apr 27, 2021

Effect of GIP After a Meal in Patients With Type 2 Diabetes

An interventional study of GIP(3-30)NH2 and Peripheral venous cannulation in Type2 Diabetes, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-27.

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

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study summary

The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.

02

Conditions studied

  • Type2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

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
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes
  • HbA1c \< 75 mmol/mol
  • BMI > 27 kg/m2
  • Stable weight (+/- 5%) during the last 3 months

Exclusion criteria

Exclusion Criteria:

  • Treatment with medicine or dietary supplements that cannot the paused for 12 hours
  • More than 14 units of alcohol weekly or abuse of drugs
  • Liver disease, estimated at plasma ALAT levels > 3 x normal value or INR outside normal range
  • Reduced kidney function (estimated at eGFR \< 60 ml/min/1,73 m2)
  • Severe arteriosclerotic heart disease or heart failure (NYHA III or IV)
  • Low red blood cell count (hemoglobin \< 8.3 mmol/l
  • Special diet or planned weight change during the trial period
  • Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial
05

Study design

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

Study arms

  • Experimental
    GIP(3-30)NH2

    GIP receptor antagonist

    Other: GIP(3-30)NH2 · Other: Peripheral venous cannulation

  • Placebo comparator
    Placebo

    Placebo (saline infusions)

    Other: Peripheral venous cannulation

  • Active comparator
    GLP-1

    Other: Peripheral venous cannulation · Other: GLP-1

  • Experimental
    GLP-1 + GIP(3-30)NH2

    Other: GIP(3-30)NH2 · Other: Peripheral venous cannulation · Other: GLP-1

Interventions

  • OtherGIP(3-30)NH2

    Peptide derived from the naturally occuring gut hormone GIP

  • OtherPeripheral venous cannulation

    Intravenous access for infusions

  • OtherGLP-1

    Peptide infusion

06

What researchers measure

Primary outcomes

  1. Glucagon

    Plasma levels of glucagon after a meal in patients with type 2-diabetes

    Time frame: 8 weeks - 6 months

07

Study locations

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03702660
Lead sponsor
University Hospital, Gentofte, Copenhagen
Responsible party
Signe Stensen (MD, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Oct 11, 2018
Start date
Aug 1, 2017
Primary completion
Jan 23, 2018
Completion
Jan 23, 2018
Last update
Apr 27, 2021

Study contacts

Signe Stensen, MD
principal investigator · Center for Diabetes Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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