Risk of Hypoglycemia in Type 2 Diabetes
This study has been completed.
University of Giessen
First Posted: August 14, 2008
Last Update Posted: October 26, 2016
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Linn, University of Giessen
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.
|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:
U.S. FDA Resources
Further study details as provided by Thomas Linn, University of Giessen:
Primary Outcome Measures:
- Number of hypoglycemic events [ Time Frame: 3 days ]
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 ]
|Study Start Date:||July 2008|
|Study Completion Date:||October 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Type 2 diabetic patients on glibenclamide at individual dosage up to 7 mg/day for more than one year prone to hypoglycemic events
Taking a single dose of 3.5 mg glibenclamide
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.
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