NCT00321321CompletedPhase 2
Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes
University Hospital, Gentofte, Copenhagen2 sites in 1 country12 target enrollmentStarted: May 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Insulin Secretion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •Pregnancy and/or breastfeeding
Outcomes
Primary Outcomes
Insulin Secretion
Time Frame: 0 - 90 minutes
area under the curve AUC and insulin secretion rate
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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