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Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515801
Recruitment Status : Completed
First Posted : August 14, 2007
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: glibenclamide Drug: placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of a Sulfonylurea Compound on the Glucagon Response to Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus
Study Start Date : June 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. rate of glucose recovery following insulin induced hypoglycemia with and without glibenclamide pretreatment [ Time Frame: cross-sectional ]
  2. cognitive function during insulin induced hypoglycemia with and without glibenclamide pretreatment [ Time Frame: cross-sectional ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00515801

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University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Stefan Bilz, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00515801     History of Changes
Other Study ID Numbers: EKBB 57/07 SB
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

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

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