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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 Sharp & Dohme Corp.
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

August 13, 2008
August 13, 2008
July 2008
September 2009   (final data collection date for primary outcome measure)
Number of hypoglycemic events [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ]
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
Other Name: Glibenclamide
1
Type 2 diabetic patients on glibenclamide
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.
 
Active, not recruiting
12
December 2009
September 2009   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00734669
EC 84/08
No
Thomas Linn/ Principal investigator, Clinical Research Unit, Justus Liebig University
University of Giessen
Merck Sharp & Dohme Corp.
Not Provided
University of Giessen
July 2008

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