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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.
Information provided by:
University Hospital, Gentofte, Copenhagen Identifier:
First received: May 2, 2006
Last updated: June 23, 2015
Last verified: September 2008
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
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

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

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

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)

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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Kasper Aaboe, Gentofte University Hospital 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: June 23, 2015

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 processed this record on August 21, 2017