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The Beta Cell Responsiveness to Glucose-Dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00321321
First received: May 2, 2006
Last updated: October 1, 2008
Last verified: September 2008

May 2, 2006
October 1, 2008
May 2006
March 2007   (final data collection date for primary outcome measure)
Insulin Secretion [ Time Frame: 0 - 90 minutes ] [ Designated as safety issue: No ]
Insulin secretion
Complete list of historical versions of study NCT00321321 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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The Beta Cell Responsiveness to Glucose-Dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus, Type 2
Drug: Sulfonylurea
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00321321
KA-05011
Yes
Kasper Aaboe, Gentofte University Hospital
University Hospital, Gentofte, Copenhagen
Not Provided
Principal Investigator: Kasper Aaboe, M.D. Gentofte University Hospital
University Hospital, Gentofte, Copenhagen
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP