Back to resultsSulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
glibenclamide
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 1 focused on measuring diabetes mellitus type 1, hypoglycemia, sulfonylurea, glucagon
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
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Glibenclamide 5 mg tablets
placebo capsules
Outcomes
Primary Outcome Measures
plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment
Secondary Outcome Measures
rate of glucose recovery following insulin induced hypoglycemia with and without glibenclamide pretreatment
cognitive function during insulin induced hypoglycemia with and without glibenclamide pretreatment
Full Information
NCT ID
NCT00515801
First Posted
August 13, 2007
Last Updated
March 8, 2012
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00515801
Brief Title
Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM
Official Title
Effect of a Sulfonylurea Compound on the Glucagon Response to Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
diabetes mellitus type 1, hypoglycemia, sulfonylurea, glucagon
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Glibenclamide 5 mg tablets
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo capsules
Intervention Type
Drug
Intervention Name(s)
glibenclamide
Other Intervention Name(s)
Daonil 5 mg pills
Intervention Description
glibenclamide 15 mg single dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo capsules, single dose
Primary Outcome Measure Information:
Title
plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment
Time Frame
cross-sectional
Secondary Outcome Measure Information:
Title
rate of glucose recovery following insulin induced hypoglycemia with and without glibenclamide pretreatment
Time Frame
cross-sectional
Title
cognitive function during insulin induced hypoglycemia with and without glibenclamide pretreatment
Time Frame
cross-sectional
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Bilz, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24023652
Citation
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.
Results Reference
derived
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Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM
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