NCT00515801

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

First QC Date

August 13, 2007

Last Update Submit

March 8, 2012

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes mellitus type 1hypoglycemiasulfonylureaglucagon

Outcome Measures

Primary Outcomes (1)

  • plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment

    cross-sectional

Secondary Outcomes (2)

  • rate of glucose recovery following insulin induced hypoglycemia with and without glibenclamide pretreatment

    cross-sectional

  • cognitive function during insulin induced hypoglycemia with and without glibenclamide pretreatment

    cross-sectional

Study Arms (2)

A

EXPERIMENTAL

Glibenclamide 5 mg tablets

Drug: glibenclamide

B

PLACEBO COMPARATOR

placebo capsules

Drug: placebo

Interventions

glibenclamideDRUG

glibenclamide 15 mg single dose

Also known as: Daonil 5 mg pills
A
placeboDRUG

placebo capsules, single dose

B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 24023652DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Stefan Bilz, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

June 1, 2007

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

CH(1)