Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-12-31

Brief Summary

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Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.

Detailed Description

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Conditions

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Diabetes Mellitus Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Interventions

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Detemir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects male or female
* Age 18-50 years
* Female subjects save contraception
* Ability to take part in the study
* Signed consent

Exclusion Criteria

* Chronic disease
* Acute disease during 4 weeks prior to the study
* Pregnancy
* Drug treatment other than hormonal contraception

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Andreas Fritsche, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University of Tübingen, Medical Department

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2005-003940-79

Identifier Type: -

Identifier Source: org_study_id