Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM
We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients with type 1 diabetes when compared to type 1 diabetic patients with residual insulin secretion (C-peptide positive).
Diabetes Mellitus, Type 1
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Effect of a Sulfonylurea Compound on the Glucagon Response to Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus|
- plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment [ Time Frame: cross-sectional ]
- rate of glucose recovery following insulin induced hypoglycemia with and without glibenclamide pretreatment [ Time Frame: cross-sectional ]
- cognitive function during insulin induced hypoglycemia with and without glibenclamide pretreatment [ Time Frame: cross-sectional ]
|Study Start Date:||June 2007|
Glibenclamide 5 mg tablets
glibenclamide 15 mg single dose
Other Name: Daonil 5 mg pills
Placebo Comparator: B
placebo capsules, single dose
The glucagon response during insulin induced hypoglycemia and rate of glucose recovery will be monitored in 10 C-peptide positive and 10 C-Peptide negative patients with type 1 DM following the application of glibenclamide and placebo in a randomized, single-blind, cross-over study.
Cognitive function during hypoglycemia with and without glibenclamide pretreatment will be a secondary outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515801
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Stefan Bilz, MD||University Hospital, Basel, Switzerland|