This trial is active, not recruiting.

Condition type 2 diabetes
Treatment glibenclamide
Sponsor University of Giessen
Collaborator Merck Sharp & Dohme Corp.
Start date July 2008
End date September 2009
Trial size 12 participants
Trial identifier NCT00734669, EC 84/08


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Type 2 diabetic patients on glibenclamide
glibenclamide Glibenclamide
Taking a single dose of 3.5 mg glibenclamide

Primary Outcomes

Number of hypoglycemic events
time frame: 3 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Risk of Hypoglycemia in Type 2 Diabetes - Effects of Glibenclamide and Exercise on Cardiovascular, Hormonal, and Metabolic Parameters
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by University of Giessen.