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

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Sulfonylurea

Study type: Interventional

Funder types: Other

Identifiers

NCT00321321

KA-05011

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)