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Risk of Hypoglycemia in Type 2 Diabetes

U

University of Giessen

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Drug: Glibenclamide

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00734669
EC 84/08

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

1
Description:
Type 2 diabetic patients on glibenclamide at individual dosage up to 7 mg/day for more than one year prone to hypoglycemic events
Treatment:
Drug: Glibenclamide

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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