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Risk of Hypoglycemia in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Linn, University of Giessen
ClinicalTrials.gov Identifier:
NCT00734669
First received: August 13, 2008
Last updated: October 24, 2016
Last verified: October 2016

August 13, 2008
October 24, 2016
July 2008
January 2016   (Final data collection date for primary outcome measure)
Number of hypoglycemic events [ Time Frame: 3 days ]
Same as current
Complete list of historical versions of study NCT00734669 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Risk of Hypoglycemia in Type 2 Diabetes
Risk of Hypoglycemia in Type 2 Diabetes - Effects of Glibenclamide and Exercise on Cardiovascular, Hormonal, and Metabolic Parameters
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Type 2 diabetes
Type 2 Diabetes
Drug: Glibenclamide
Taking a single dose of 3.5 mg glibenclamide
1
Type 2 diabetic patients on glibenclamide at individual dosage up to 7 mg/day for more than one year prone to hypoglycemic events
Intervention: Drug: Glibenclamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00734669
EC 84/08
No
Not Provided
No
Not Provided
Thomas Linn, University of Giessen
University of Giessen
Merck Sharp & Dohme Corp.
Not Provided
University of Giessen
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP