Risk of Hypoglycemia in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Risk of Hypoglycemia in Type 2 Diabetes - Effects of Glibenclamide and Exercise on Cardiovascular, Hormonal, and Metabolic Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734669
• Other study ID #: EC 84/08
• Status: Completed
• Phase: N/A
• First received: August 13, 2008
• Last updated: October 24, 2016
• Start date: July 2008
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypoglycemia
• Type 2 Diabetes

Intervention

Drug:
• Glibenclamide
Taking a single dose of 3.5 mg glibenclamide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypoglycemic events		3 days	Yes
Secondary	Secretion of hormones increasing blood glucose, effect of exercise on hypoglycemic events, postprandial glucose excursions, heart rate and forearm blood flow at hypoglycemia		3 days	Yes