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Risk of Hypoglycemia in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Giessen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT00734669
First received: August 13, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored via a continuous glucose monitoring system in a standardized clinical setting during day and night time, implementing meals and exercise of moderate intensity performed in the postprandial state.


Condition Intervention
Type 2 Diabetes
 Drug: Glibenclamide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk of Hypoglycemia in Type 2 Diabetes - Effects of Glibenclamide and Exercise on Cardiovascular, Hormonal, and Metabolic Parameters

Resource links provided by NLM:

Drug Information available for: Glyburide
U.S. FDA Resources

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Number of hypoglycemic events [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secretion of hormones increasing blood glucose, effect of exercise on hypoglycemic events, postprandial glucose excursions, heart rate and forearm blood flow at hypoglycemia [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Type 2 diabetic patients on glibenclamide
 Drug: Glibenclamide
Taking a single dose of 3.5 mg glibenclamide
Other Name: Glibenclamide

Detailed Description:

The day-to-day change of blood glucose is associated with the frequency of vascular complications and the quality of life of diabetic patients. In this study the frequency of hypoglycemic events in combination with postprandial hyperglycemia in type 2 diabetic patients on oral insulinotropic therapy will be observed. Using more sophisticated technology than before the probability of type 2 diabetic patients on glibenclamide to experience hypoglycemic episodes will be registered. Hypoglycemia is prone to cardiovascular complications in type 2 diabetic patients due to concomitant dysregulation of blood flow. With standardized test meals followed by exercise in a clinical setting hormonal counterregulation and cardiovascular parameters associated with hypoglycemia will be identified. The acute effect of different conditions of exercise and a single dose of either glibenclamide or placebo will be followed each day during the total three-day observation period. Thus we will evaluate the frequency of and the risk factors associated with hypoglycemia and meal-related hyperglycemia in type 2 diabetic patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 diabetes

Criteria

Inclusion Criteria:

  • Type 2 diabetes on glibenclamide with or without
  • Glycated hemoglobin ≤ 7.5%
  • Stable dosage for three weeks

Exclusion Criteria:

  • HbA1c > 7.5%
  • Fasting C-peptide below normal
  • Concurrent infectious disease
  • Pregnancy
  • Malignant disease
  • Inability to give informed consent
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Thomas Linn/ Principal investigator, Clinical Research Unit, Justus Liebig University
ClinicalTrials.gov Identifier: NCT00734669     History of Changes
Other Study ID Numbers: EC 84/08
Study First Received: August 13, 2008
Last Updated: August 13, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
Diabetes
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013