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Risk of Hypoglycemia in Type 2 Diabetes

NCT ID: NCT00734669

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Keywords

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Diabetes Hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Type 2 diabetic patients on glibenclamide at individual dosage up to 7 mg/day for more than one year prone to hypoglycemic events

Glibenclamide

Intervention Type DRUG

Taking a single dose of 3.5 mg glibenclamide

Interventions

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Glibenclamide

Taking a single dose of 3.5 mg glibenclamide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Thomas Linn

Univ.-Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EC 84/08

Identifier Type: -

Identifier Source: org_study_id