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
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: glibenclamide
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment [ Time Frame: cross-sectional ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: June 2007
Arms Assigned Interventions
Experimental: A
Glibenclamide 5 mg tablets
Drug: glibenclamide
glibenclamide 15 mg single dose
Other Name: Daonil 5 mg pills
Placebo Comparator: B
placebo capsules
Drug: placebo
placebo capsules, single dose

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515801

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Stefan Bilz, MD University Hospital, Basel, Switzerland
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00515801     History of Changes
Other Study ID Numbers: EKBB 57/07 SB
Study First Received: August 13, 2007
Last Updated: March 8, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
diabetes mellitus type 1
hypoglycemia
sulfonylurea
glucagon

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glyburide
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on April 17, 2014