Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00515801
First received: August 13, 2007
Last updated: March 8, 2012
Last verified: March 2012

August 13, 2007
March 8, 2012
June 2007
Not Provided
plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment [ Time Frame: cross-sectional ]
Same as current
Complete list of historical versions of study NCT00515801 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM
Effect of a Sulfonylurea Compound on the Glucagon Response to Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus

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).

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Diabetes Mellitus, Type 1
  • Drug: glibenclamide
    glibenclamide 15 mg single dose
    Other Name: Daonil 5 mg pills
  • Drug: placebo
    placebo capsules, single dose
  • Experimental: A
    Glibenclamide 5 mg tablets
    Intervention: Drug: glibenclamide
  • Placebo Comparator: B
    placebo capsules
    Intervention: Drug: placebo
Seelig E, Bilz S, Keller U, Meienberg F, Christ-Crain M. Concentrations of the stress hormone copeptin increase upon hypoglycaemia in patients with type 1 diabetes dependent of hypoglycaemia awareness. PLoS One. 2013 Aug 30;8(8):e72876. doi: 10.1371/journal.pone.0072876.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Not Provided
Not Provided

Inclusion Criteria:

  • Patients aged 18 to 50 years
  • Patients diagnosed with C-peptide negative diabetes type 1 (C-peptide <200 pmol/L 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l)
  • Patients diagnosed with C-peptide positive diabetes type 1 (C-peptide > 500 pmol/l 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l)
  • Stable metabolic control; HbA1c levels <8.0 % and without episodes of antecedent severe hypoglycemias in the past four weeks

Exclusion Criteria:

  • Patients treated with medications potentially interfering with glucose metabolism, such as systemic steroids, immunosuppressive drugs (cyclosporine, tacrolimus, sirolimus), highly active antiretroviral therapy
  • History coronary artery disease
  • History of epilepsy or seizures
  • Current smokers
  • Any significant or unstable hepatic, cardiac, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease.
  • Pregnant or breast feeding women
  • Woman of childbearing potential not using a reliable method of birth control such as oral contraceptives or IUD.
  • Subjects refusing or unable to give written informed consent
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00515801
EKBB 57/07 SB
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Stefan Bilz, MD University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP