- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770910
The Effect of GIP(3-30)NH2 (GA-10)
March 25, 2020 updated by: Lærke Smidt Gasbjerg, University Hospital, Gentofte, Copenhagen
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.
Six study hyperglycemic clamps (10 mmol/l) pr. participant.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Copenhagen
-
Gentofte, Copenhagen, Denmark, 2900
- Clinical Metabolic Physiology
-
-
Gentofte
-
Copenhagen, Gentofte, Denmark, 2900
- Clinical Metabolic Physiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy
- BMI 19-28 kg/m*m
- Stable body weight
Exclusion Criteria:
- Diabetes
- Anemia
- First-degree relatives with diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo+placebo
Saline infusions
|
Placebo (vehicle for infusions)
|
Active Comparator: GIP+placebo
GIP(1-42), receptor agonist
|
Placebo (vehicle for infusions)
GIP(1-42)
|
Experimental: GIP+dose 1
GIP(1-42) and lowest dose of GIP(3-30)NH2
|
GIP(1-42)
GIP receptor antagonist
|
Experimental: GIP+dose 2
GIP(1-42) and dose of GIP(3-30)NH2
|
GIP(1-42)
GIP receptor antagonist
|
Experimental: GIP+dose 3
GIP(1-42) and dose of GIP(3-30)NH2
|
GIP(1-42)
GIP receptor antagonist
|
Experimental: GIP+dose4
GIP(1-42) and highest dose of GIP(3-30)NH2
|
GIP(1-42)
GIP receptor antagonist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin secretion
Time Frame: 8 weeks
|
Insulin secretion rates (ISR) calculated from serum levels of C-peptide
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2018
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
December 6, 2018
First Submitted That Met QC Criteria
December 7, 2018
First Posted (Actual)
December 10, 2018
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SDCC_CMP_GA-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
IPD will not be shared with other researchers unless data management agreements are signed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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