Type 2 Diabetes MellitusGASOLIN IINCT03526289
GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
A study testing GIP1-42 infusion and Saline in people with Type 2 Diabetes Mellitus and Overweight and Obesity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Overweight and Obesity
- What is being tested?
- GIP1-42 infusion and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2017to 24 Oct 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian men
- Age between 18 and 70 years
- Body mass index (BMI) between 25 and 40 kg/m2
- Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mM (<8.5 %)
- In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
- Informed consent
Who cannot join
- Anaemia (haemoglobin outside normal range)
- Any current or prior gastrointestinal disease that may interfere with the endpoint variables
- Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder.
- Nephropathy (serum creatinine above normal range and/or albuminuria).
- Anorexia, bulimia or binge eating disorder
- Allergy or intolerance to ingredients included in the standardised meals
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- Tobacco smoking
- Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
- Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
- Any physical or psychological condition that the investigator feels would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.
Read the detailed description
The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Being tested
- GIP1-42 infusion, Saline
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP1-42 infusionBiological
5-hour GIP1-42 infusion (time point 0-300 minutes)
SalineOther
5-hour infusion of saline (placebo) (time point 0-300 minutes)
| Study group | Role | What they receive |
|---|---|---|
| GIP infusion | Active comparator | 5 hours of continuously GIP1-42 infusion Receives: Biological: GIP1-42 infusion |
| Saline | Placebo comparator | 5 hours of continuously saline infusion Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
food intake
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
Measured: time point 300-330 minutes
Secondary outcomes (14)
Appetite
Appetite rated on visual analogue scales (0-10 mm)
Measured: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
satiety
Satiety rated on visual analogue scales (0-10 mm)
Measured: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
prospective food consumption
prospective food consumption rated on visual analogue scales (0-10 mm)
Measured: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
fullness
fullness rated on visual analogue scales (0-10 mm)
Measured: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Thirst
Thirst rated on visual analogue scales (0-10 mm)
Measured: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Nausea
Nausea rated on visual analogue scales (0-10 mm)
Measured: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Energy expenditure
resting energy expenditure measured by indirect calorimetry (kcal/day)
Measured: measured at baseline and at time point 250 minutes
gastric emptying
acetaminophen test
Measured: ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
gallbladder emptying
gallbladder emptying evaluated by ultrasound
Measured: at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes
glucagon responses
blood samples
Measured: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Insulin responses
blood samples
Measured: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
C-peptide responses
blood samples
Measured: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
gut hormone responses
Blood samples
Measured: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
bone turnover markers
Blood samples
Measured: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start8 Nov 2017
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand Pharma
- Responsible party
- Principal investigator, Natasha Chidekel Bergmann, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526289
- Sponsor's protocol ID
- H-16031728
- Acronym
- GASOLIN II
- Status last verified
- Dec 2018
- First submitted
- 24 Oct 2017
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bergmann NC, Gasbjerg LS, Heimburger SM, Krogh LSL, Dela F, Hartmann B, Holst JJ, Jessen L, Christensen MB, Vilsboll T, Lund A, Knop FK. No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):588-596. doi: 10.2337/dc19-0578. Epub 2020 Jan 16.
PubMed 31949084
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
- ClinicalTrials.gov ID
- NCT03526289
- Acronym / sponsor ID
- GASOLIN II / H-16031728
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Zealand Pharma
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 16 May 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 primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.
Detailed description
The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIP infusion | Active comparator | Biological: GIP1-42 infusion5 hours of continuously GIP1-42 infusion |
| Saline | Placebo comparator | Other: Saline5 hours of continuously saline infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caucasian men
- Age between 18 and 70 years
- Body mass index (BMI) between 25 and 40 kg/m2
- Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mM (<8.5 %)
- In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
Key exclusion criteria (10 listed)
- Anaemia (haemoglobin outside normal range)
- Any current or prior gastrointestinal disease that may interfere with the endpoint variables
- Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder.
- Nephropathy (serum creatinine above normal range and/or albuminuria).
- Anorexia, bulimia or binge eating disorder
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 |
|---|---|---|
| GIP1-42 infusion5-hour GIP1-42 infusion (time point 0-300 minutes) | Biological | GIP infusion |
| Saline5-hour infusion of saline (placebo) (time point 0-300 minutes) | Other | Saline |
Primary outcome
food intake
Time frame: time point 300-330 minutes
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
14 secondary outcomes
Appetite
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
satiety
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
prospective food consumption
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
fullness
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Thirst
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Nausea
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Energy expenditure
Time frame: measured at baseline and at time point 250 minutes
gastric emptying
Time frame: ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
gallbladder emptying
Time frame: at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes
glucagon responses
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Insulin responses
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
C-peptide responses
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
gut hormone responses
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
bone turnover markers
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
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 5 Dec 2018.
- Derived from this study: PubMed 31949084Bergmann NC, Gasbjerg LS, Heimburger SM, Krogh LSL, Dela F, Hartmann B, Holst JJ, Jessen L, Christensen MB, Vilsboll T, Lund A, Knop FK. No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):588-596. doi: 10.2337/dc19-0578. Epub 2020 Jan 16.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIP1-42 infusion and Saline in people with Type 2 Diabetes Mellitus and Overweight and Obesity, 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 6 inclusion and 10 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 5 Dec 2018. 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?
food intake (time frame: time point 300-330 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526289, which also lists 1 linked publication.
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 5 Dec 2018.