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

Tracking Information
First Received Date ^ICMJE	August 13, 2008
Last Updated Date	August 13, 2008
Start Date ^ICMJE	July 2008
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 13, 2008)	Number of hypoglycemic events [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: August 13, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Risk of Hypoglycemia in Type 2 Diabetes
Official Title ^ICMJE	Risk of Hypoglycemia in Type 2 Diabetes - Effects of Glibenclamide and Exercise on Cardiovascular, Hormonal, and Metabolic Parameters
Brief Summary	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.
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Type 2 diabetes
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: Glibenclamide Taking a single dose of 3.5 mg glibenclamide Other Name: Glibenclamide
Study Group/Cohort (s)	1 Type 2 diabetic patients on glibenclamide Intervention: Drug: Glibenclamide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	12
Estimated Completion Date	December 2009
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00734669
Other Study ID Numbers ^ICMJE	EC 84/08
Has Data Monitoring Committee	No
Responsible Party	Thomas Linn/ Principal investigator, Clinical Research Unit, Justus Liebig University
Study Sponsor ^ICMJE	University of Giessen
Collaborators ^ICMJE	Merck
Investigators ^ICMJE	Not Provided
Information Provided By	University of Giessen
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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