Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00515801

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 II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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:

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Glyburide Glucagon

U.S. FDA Resources

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 ]

Estimated Enrollment:	20
Study Start Date:	June 2007
Estimated Study Completion Date:	February 2008

Arms	Assigned Interventions
A: Experimental Glibenclamide 5 mg tablets	Drug: glibenclamide glibenclamide 15 mg single dose
B: Placebo Comparator 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

Contacts

Contact: Stefan Bilz, MD	0041714941228	stefan.bilz@kssg.ch
Contact: Eleonora Seelig, MD	0041 61 328 6814	eseelig@uhbs.ch

Locations

Switzerland
University Hospital Basel	Recruiting
Basel, Switzerland, 4031
Contact: Stefan Bilz, MD 0041714941228 Stefan.Bilz@kssg.ch
Contact: Eleonora A Seelig, MD 0041613286814 eseelig@uhbs.ch
Principal Investigator: Stefan Bilz, MD

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:

Stefan Bilz, MD

University Hospital Basel

More Information

No publications provided

Study ID Numbers:	EKBB 57/07 SB
Study First Received:	August 13, 2007
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00515801 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:

diabetes mellitus type 1
hypoglycemia
sulfonylurea
glucagon

Study placed in the following topic categories:

Glyburide
Metabolic Diseases
Autoimmune Diseases
Hormone Antagonists
Glucagon
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1

Hypoglycemia
Hormones
Insulin
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Glyburide
Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus

Endocrine System Diseases
Hypoglycemia
Hormones
Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Therapeutic Uses
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 04, 2009