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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Sulfonylurea
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Insulin Secretion [ Time Frame: 0 - 90 minutes ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2006
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321321

Locations
Denmark
Department of Internal Medicine, Gentofte University Hospital
Hellerup, Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Kasper Aaboe, M.D. Gentofte University Hospital
  More Information

No publications provided

Responsible Party: Kasper Aaboe, Gentofte University Hospital
ClinicalTrials.gov Identifier: NCT00321321     History of Changes
Other Study ID Numbers: KA-05011
Study First Received: May 2, 2006
Results First Received: September 29, 2008
Last Updated: October 1, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by University Hospital, Gentofte, Copenhagen:
Type 2 diabetes mellitus
Glucose dependent insulinotropic polypeptide
Sulfonylurea compounds
 insulin secretion
Sulfonylurea receptor subunit-SUR1
Impaired incretin effect

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastric Inhibitory Polypeptide
Incretins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013