Phase 2 N=12 Diagnostic

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

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT00321321 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2008

Primary outcome: Primary: Insulin Secretion — 56766 pmol/l * 90 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sulfonylurea (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospital, Gentofte, Copenhagen
Primary completion: Mar 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin Secretion	56766	—

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.

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

View full record on ClinicalTrials.gov →

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.