Endocrine - OtherGA-10NCT03770910
The Effect of GIP(3-30)NH2
A study testing GIP receptor antagonist, GIP receptor agonist and Saline in people with Endocrine - Other, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial summary
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endocrine - Other
- What is being tested?
- GIP receptor antagonist, GIP receptor agonist and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesDenmark
- Study dates
- 6 Dec 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- BMI 19-28 kg/m*m
- Stable body weight
Who cannot join
- Diabetes
- Anemia
- First-degree relatives with diabetes
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Clinical Metabolic Physiology
Copenhagen, Gentofte, 2900
Clinical Metabolic Physiology
Gentofte Municipality, Copenhagen, 2900
About this study
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.
Read the 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.
- Conditions
- Endocrine - Other
- Being tested
- GIP receptor antagonist, GIP receptor agonist, Saline
- Keywords
- GIP, Insulin secretin, Incretin hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP receptor antagonistOther
GIP receptor antagonist
GIP receptor agonistOther
GIP(1-42)
SalineOther
Placebo (vehicle for infusions)
| Study group | Role | What they receive |
|---|---|---|
| Placebo+placebo | Placebo comparator | Saline infusions Receives: Other: Saline |
| GIP+placebo | Active comparator | GIP(1-42), receptor agonist Receives: Other: GIP receptor agonist; Other: Saline |
| GIP+dose 1 | Experimental | GIP(1-42) and lowest dose of GIP(3-30)NH2 Receives: Other: GIP receptor antagonist; Other: GIP receptor agonist |
| GIP+dose 2 | Experimental | GIP(1-42) and dose of GIP(3-30)NH2 Receives: Other: GIP receptor antagonist; Other: GIP receptor agonist |
| GIP+dose 3 | Experimental | GIP(1-42) and dose of GIP(3-30)NH2 Receives: Other: GIP receptor antagonist; Other: GIP receptor agonist |
| GIP+dose4 | Experimental | GIP(1-42) and highest dose of GIP(3-30)NH2 Receives: Other: GIP receptor antagonist; Other: GIP receptor agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretion
Insulin secretion rates (ISR) calculated from serum levels of C-peptide
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start6 Dec 2018
- Primary completion1 Mar 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine - OtherStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, University of Copenhagen
- Responsible party
- Principal investigator, Lærke Smidt Gasbjerg, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770910
- Sponsor's protocol ID
- SDCC_CMP_GA-10
- Acronym
- GA-10
- Status last verified
- Mar 2020
- First submitted
- 6 Dec 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers unless data management agreements are signed.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of GIP(3-30)NH2
- ClinicalTrials.gov ID
- NCT03770910
- Acronym / sponsor ID
- GA-10 / SDCC_CMP_GA-10
- Conditions
- Endocrine - Other
- Keywords
- GIP, Insulin secretin, Incretin hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, University of Copenhagen
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo+placebo | Placebo comparator | Other: SalineSaline infusions |
| GIP+placebo | Active comparator | Other: GIP receptor agonist, Other: SalineGIP(1-42), receptor agonist |
| GIP+dose 1 | Experimental | Other: GIP receptor antagonist, Other: GIP receptor agonistGIP(1-42) and lowest dose of GIP(3-30)NH2 |
| GIP+dose 2 | Experimental | Other: GIP receptor antagonist, Other: GIP receptor agonistGIP(1-42) and dose of GIP(3-30)NH2 |
| GIP+dose 3 | Experimental | Other: GIP receptor antagonist, Other: GIP receptor agonistGIP(1-42) and dose of GIP(3-30)NH2 |
| GIP+dose4 | Experimental | Other: GIP receptor antagonist, Other: GIP receptor agonistGIP(1-42) and highest dose of GIP(3-30)NH2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- BMI 19-28 kg/m*m
- Stable body weight
Key exclusion criteria (3 listed)
- Diabetes
- Anemia
- First-degree relatives with diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIP receptor antagonistGIP receptor antagonist | Other | GIP+dose 1, GIP+dose 2, GIP+dose 3, GIP+dose4 |
| GIP receptor agonistGIP(1-42) | Other | GIP+dose 1, GIP+dose 2, GIP+dose 3, GIP+dose4, GIP+placebo |
| SalinePlacebo (vehicle for infusions) | Other | GIP+placebo, Placebo+placebo |
Primary outcome
Insulin secretion
Time frame: 8 weeks
Insulin secretion rates (ISR) calculated from serum levels of C-peptide
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers unless data management agreements are signed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIP receptor antagonist, GIP receptor agonist and Saline in people with Endocrine - Other, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin secretion (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.