Diabetes MellitusPhase 1/2NCT01048268
Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
A Phase 1/2 study testing glucose-dependent insulinotropic polypeptide in people with Diabetes Mellitus, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- glucose-dependent insulinotropic polypeptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Apr 2014
- Phase
- Phase 1/2
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
- Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
- Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
- Normal hemoglobin
- Informed consent
Who cannot join
- Unwillingness to participate or the wish to leave the present study
- HbA1c > 9 %
- Liver disease (ALAT or ASAT > 2 times normal value)
- Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
- Proliferative diabetic retinopathy (anamnetic)
- Atherosclerotic heart disease or heart failure (NYHA group III and IV)
Show all 10Show fewer
- Anemia
- Treatment with medicine which cannot be paused for 12 hours
- Pregnancy and/or breast feeding
- Fasting plasma glucose > 15 mM on the day of the experiment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine F' laboratory
Hellerup, Copenhagen County, 2900
About this study
The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose
Read the detailed description
The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.
From this, we will evaluate GIP's role as blood sugar stabilizer.
- Conditions
- Diabetes Mellitus
- Being tested
- glucose-dependent insulinotropic polypeptide, Placebo
- Keywords
- T1DM, T2DM, GIP, Glucose-dependent insulinotropic polypeptide, Incretin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose-dependent insulinotropic polypeptideDrug
For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.
For the following 40 minutes the volunteers will receive 2 pmol/kg body weight
PlaceboDrug
copy GIP infusion rates
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Drug: glucose-dependent insulinotropic polypeptide; Drug: Placebo |
| Patients with Type 1 diabetes mellitus | Experimental | Not described Receives: Drug: glucose-dependent insulinotropic polypeptide; Drug: Placebo |
| Patients with type 2 diabetes mellitus | Experimental | Not described Receives: Drug: glucose-dependent insulinotropic polypeptide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon
Measured: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit
Secondary outcomes (1)
The difference between the amount of infused glucose and the insulin responses
Measured: will be measured at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2014
- Study completionApr 2014
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 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikkel Christensen, University Hospital, Gentofte, Copenhagen
- Investigators
- Mikkel Christensen, MD, Principal investigator, Bispebjerg Hospital, CopenhagenFilip K Knop, MD PhD, Study director, Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048268
- Sponsor's protocol ID
- GIP HYPO (MC)
- Status last verified
- Jul 2015
- First submitted
- 12 Jan 2010
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.
PubMed 31665480
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
- ClinicalTrials.gov ID
- NCT01048268
- Acronym / sponsor ID
- GIP HYPO (MC)
- Conditions
- Diabetes Mellitus
- Keywords
- T1DM, T2DM, GIP, Glucose-dependent insulinotropic polypeptide, Incretin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Jan 2010 (estimated)
- 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 purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose
Detailed description
The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.
From this, we will evaluate GIP's role as blood sugar stabilizer.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Drug: glucose-dependent insulinotropic polypeptide, Drug: Placebo |
| Patients with Type 1 diabetes mellitus | Experimental | Drug: glucose-dependent insulinotropic polypeptide, Drug: Placebo |
| Patients with type 2 diabetes mellitus | Experimental | Drug: glucose-dependent insulinotropic polypeptide, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
- Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
- Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
- Normal hemoglobin
- Informed consent
Key exclusion criteria (10 listed)
- Unwillingness to participate or the wish to leave the present study
- HbA1c > 9 %
- Liver disease (ALAT or ASAT > 2 times normal value)
- Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
- Proliferative diabetic retinopathy (anamnetic)
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 |
|---|---|---|
| glucose-dependent insulinotropic polypeptideFor the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight. For the following 40 minutes the volunteers will receive 2 pmol/kg body weight | Drug | Healthy volunteers, Patients with Type 1 diabetes mellitus, Patients with type 2 diabetes mellitus |
| Placebocopy GIP infusion rates | Drug | Healthy volunteers, Patients with Type 1 diabetes mellitus, Patients with type 2 diabetes mellitus |
Primary outcome
The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon
Time frame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit
1 secondary outcome
The difference between the amount of infused glucose and the insulin responses
Time frame: will be measured at each visit
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 14 Jul 2015.
- Derived from this study: PubMed 31665480Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.
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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.
Mikkel Christensen, MD principal investigator
Bispebjerg Hospital, Copenhagen
Filip K Knop, MD PhD study director
Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing glucose-dependent insulinotropic polypeptide in people with Diabetes Mellitus, 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 5 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 14 Jul 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon (time frame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit). 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 NCT01048268, 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 14 Jul 2015.