Diabetes Mellitus, Type 2Phase 2NCT00321321
The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes
A Phase 2 study testing Sulfonylurea in people with Diabetes Mellitus, Type 2, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Sulfonylurea
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- May 2006to Apr 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus diagnosed according to WHO criteria
- Diet and/or metformin treatment
- HbA1c > 7,0% for metformin treated patients
- HbA1c > 7,5% for diet treated patients
- Age: 18 years or older
- 25 > BMI > 40 kg/m2
- Signed informed consent
- Sufficient birth control in case of child bearing capacity
Who cannot join
- Proliferative retinopathy
- Diabetic nephropathy with s-creatinine > 130 microM and/or macroalbuminuria
- Liver disease (ALAT > 2 x normal value)
- CAD (NYHA group III or IV)
- Positive screening for islet-cell and/or GAD-65 autoantibodies
- Type 1 diabetes i first degree relatives
Show all 9Show fewer
- Gastrointestinal surgery with intestinal resection
- Anemia
- Pregnancy and/or breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine, Gentofte University Hospital
Hellerup, Copenhagen, 2900
About this study
Official title: Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes
The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Sulfonylurea
- Keywords
- Type 2 diabetes mellitus, Glucose dependent insulinotropic polypeptide, Sulfonylurea compounds, insulin secretion, Sulfonylurea receptor subunit-SUR1, Impaired incretin effect
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfonylureaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Secretion
area under the curve AUC and insulin secretion rate
Measured: 0 - 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Kasper Aaboe, M.D., Principal investigator, Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321321
- Sponsor's protocol ID
- KA-05011
- Status last verified
- Sep 2008
- First submitted
- 2 May 2006
- Last updated
- 16 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00321321
- Acronym / sponsor ID
- KA-05011
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Glucose dependent insulinotropic polypeptide, Sulfonylurea compounds, insulin secretion, Sulfonylurea receptor subunit-SUR1, Impaired incretin effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Posted 2 Oct 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes mellitus diagnosed according to WHO criteria
- Diet and/or metformin treatment
- HbA1c > 7,0% for metformin treated patients
- HbA1c > 7,5% for diet treated patients
- Age: 18 years or older
Key exclusion criteria (9 listed)
- Proliferative retinopathy
- Diabetic nephropathy with s-creatinine > 130 microM and/or macroalbuminuria
- Liver disease (ALAT > 2 x normal value)
- CAD (NYHA group III or IV)
- Positive screening for islet-cell and/or GAD-65 autoantibodies
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 |
|---|---|---|
| Sulfonylurea | Drug | – |
Primary outcome
Insulin Secretion
Time frame: 0 - 90 minutes
area under the curve AUC and insulin secretion rate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kasper Aaboe, M.D. principal investigator
Gentofte University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfonylurea in people with Diabetes Mellitus, Type 2, 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 8 inclusion and 9 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 16 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 2 Oct 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 0 - 90 minutes). 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 16 Jul 2015.