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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
Completed
Conditions
Diabetes Mellitus, Type 2
Registration Number
NCT00321321
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Insulin Secretion0 - 90 minutes

area under the curve AUC and insulin secretion rate

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Internal Medicine, Gentofte University Hospital

🇩🇰

Hellerup, Copenhagen, Denmark

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