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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321321
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : October 2, 2008
Last Update Posted : July 16, 2015
Information provided by:
University Hospital, Gentofte, Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Sulfonylurea Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Insulin Secretion [ Time Frame: 0 - 90 minutes ]
    area under the curve AUC and insulin secretion rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00321321

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

Responsible Party: Kasper Aaboe, Gentofte University Hospital Identifier: NCT00321321     History of Changes
Other Study ID Numbers: KA-05011
First Posted: May 3, 2006    Key Record Dates
Results First Posted: October 2, 2008
Last Update Posted: July 16, 2015
Last Verified: September 2008

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
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs