Type2 DiabetesGA-7NCT03702660
Effect of GIP After a Meal in Patients With Type 2 Diabetes
A study testing GIP(3-30)NH2, Peripheral venous cannulation and GLP-1 in people with Type2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- GIP(3-30)NH2, Peripheral venous cannulation and GLP-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 23 Jan 2018
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes
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.
- Conditions
- Type2 Diabetes
- Being tested
- GIP(3-30)NH2, Peripheral venous cannulation, GLP-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP(3-30)NH2Other
Peptide derived from the naturally occuring gut hormone GIP
Peripheral venous cannulationOther
Intravenous access for infusions
GLP-1Other
Peptide infusion
| Study group | Role | What they receive |
|---|---|---|
| GIP(3-30)NH2 | Experimental | GIP receptor antagonist Receives: Other: GIP(3-30)NH2; Other: Peripheral venous cannulation |
| Placebo | Placebo comparator | Placebo (saline infusions) Receives: Other: Peripheral venous cannulation |
| GLP-1 | Active comparator | Not described Receives: Other: Peripheral venous cannulation; Other: GLP-1 |
| GLP-1 + GIP(3-30)NH2 | Experimental | Not described Receives: Other: GIP(3-30)NH2; Other: Peripheral venous cannulation; Other: GLP-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon
Plasma levels of glucagon after a meal in patients with type 2-diabetes
Measured: 8 weeks - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Aug 2017
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Stensen, University Hospital, Gentofte, Copenhagen
- Investigators
- Signe Stensen, MD, Principal investigator, Center for Diabetes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702660
- Sponsor's protocol ID
- GA-7
- Acronym
- GA-7
- Status last verified
- Apr 2021
- First submitted
- 30 Oct 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes
- ClinicalTrials.gov ID
- NCT03702660
- Acronym / sponsor ID
- GA-7 / GA-7
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 11 Oct 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GIP(3-30)NH2 | Experimental | Other: GIP(3-30)NH2, Other: Peripheral venous cannulationGIP receptor antagonist |
| Placebo | Placebo comparator | Other: Peripheral venous cannulationPlacebo (saline infusions) |
| GLP-1 | Active comparator | Other: Peripheral venous cannulation, Other: GLP-1 |
| GLP-1 + GIP(3-30)NH2 | Experimental | Other: GIP(3-30)NH2, Other: Peripheral venous cannulation, Other: GLP-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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(3-30)NH2Peptide derived from the naturally occuring gut hormone GIP | Other | GIP(3-30)NH2, GLP-1 + GIP(3-30)NH2 |
| Peripheral venous cannulationIntravenous access for infusions | Other | GIP(3-30)NH2, GLP-1, GLP-1 + GIP(3-30)NH2, Placebo |
| GLP-1Peptide infusion | Other | GLP-1, GLP-1 + GIP(3-30)NH2 |
Primary outcome
Glucagon
Time frame: 8 weeks - 6 months
Plasma levels of glucagon after a meal in patients with type 2-diabetes
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 27 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Signe Stensen, MD principal investigator
Center for Diabetes Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIP(3-30)NH2, Peripheral venous cannulation and GLP-1 in people with Type2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site 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 4 inclusion and 8 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Glucagon (time frame: 8 weeks - 6 months). 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 27 Apr 2021.