Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM

NCT ID: NCT00515801

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30

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).

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

A

Glibenclamide 5 mg tablets

Group Type: EXPERIMENTAL

glibenclamide

Intervention Type: DRUG

glibenclamide 15 mg single dose

B

placebo capsules

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo capsules, single dose

Interventions

glibenclamide

glibenclamide 15 mg single dose

Intervention Type: DRUG

placebo

placebo capsules, single dose

Intervention Type: DRUG

Other Intervention Names

Daonil 5 mg pills

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Bilz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, Basel, Switzerland

Countries

Switzerland

References

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. eCollection 2013.

Reference Type: DERIVED

PMID: 24023652 (View on PubMed)

Other Identifiers

EKBB 57/07 SB

Identifier Type: -

Identifier Source: org_study_id