Phase 2
Completed N=12
The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00321321 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2008
Primary outcomePrimary: Insulin Secretion — 56766 pmol/l * 90 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Secretion |
56766 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00321321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.