- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00321321
The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes
June 23, 2015 updated by: University Hospital, Gentofte, Copenhagen
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hellerup, Copenhagen, Denmark, 2900
- Department of Internal Medicine, Gentofte University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Gastrointestinal surgery with intestinal resection
- Anemia
- Pregnancy and/or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Secretion
Time Frame: 0 - 90 minutes
|
area under the curve AUC and insulin secretion rate
|
0 - 90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kasper Aaboe, M.D., Gentofte University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
May 2, 2006
First Submitted That Met QC Criteria
May 2, 2006
First Posted (Estimate)
May 3, 2006
Study Record Updates
Last Update Posted (Estimate)
July 16, 2015
Last Update Submitted That Met QC Criteria
June 23, 2015
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-05011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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