Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
GLANCE
1 other identifier
interventional
10
1 country
1
Brief Summary
Infusion of glucagon-like peptide 2 (GLP-2) during euglycaemia, hypoglycaemia and hyperglycaemia and evaluation of the effect on glucagon secretion in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2019
CompletedFirst Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedNovember 4, 2020
November 1, 2020
1.3 years
May 15, 2019
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucagon secretion
Assessed by difference in absolute plasma glucagon concentrations (measured in pmol/liter) and incremental (baseline-subtracted) area under curve (AUC) for plasma glucagon
110 minutes
Secondary Outcomes (21)
Plasma glucose
110 minutes
GLP-1
110 minutes
GLP-2
110 minutes
Insulin
110 minutes
GIP
110 minutes
- +16 more secondary outcomes
Study Arms (6)
Hyperglycaemia + GLP-2
EXPERIMENTALGlucose + GLP-2
Hyperglycaemia + Placebo
ACTIVE COMPARATORGlucose + saline
Hypoglycaemia + GLP-2
EXPERIMENTALInsulin + glucose + GLP-2
Hypoglycaemia + Saline
ACTIVE COMPARATORInsulin + glucose
Euglycaemia + GLP-2
EXPERIMENTALGLP-2
Euglycaemia + Placebo
ACTIVE COMPARATORInterventions
Human glucagon-like peptide 2
20% (w/v) glucose infusion for regulating plasma glucose
Actrapid (insulin) for lowering plasma glucose
Eligibility Criteria
You may qualify if:
- Caucasian ethnicity
- Body mass index (BMI): 18.5-27 kg/m2
- Glycated haemoglobin (HbA1c) \< 42 mmol/mol
- Normal haemoglobin (8.3-10.5 mmol/l)
- Informed and oral and written consent
You may not qualify if:
- Prediabetes, type 1 diabetes or type 2 diabetes or first-degree relatives with type 1 or type 2 diabetes
- Nephropathy (eGFR \< 60 and/or albuminuria)
- Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) \> 2 × upper normal limit
- Bilirubin \> 25 μmol/l
- Known intestinal disease or previous surgery of the intestines
- Active or recent malignant disease
- Treatment with medicine that cannot be paused for 12 hours
- Any condition considered incompatible with participation by the investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Clinical Metabolic Research
Hellerup, Copenhagen, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Filip Krag Knop, MD, PhD
Center for Clinical Metabolic Research
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
- Clinical Professor
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 17, 2019
Study Start
January 31, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared with other researchers unless data management agreements are signed.