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NCT00490893 Clinical Trial

Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

Diabetes Mellitus Clinical Trial

Official title:
Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00490893
Other study ID # 2005-003940-79
Secondary ID
Status Terminated
Phase Phase 4
First received June 22, 2007
Last updated June 22, 2007
Start date March 2006
Est. completion date December 2006

Study information
Verified date June 2007
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Detemir

Locations
Country Name City State
Germany University of Tübingen, Medical Department Tübingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hormone response to hypoglycemia (Glucagon)
Primary Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia
Secondary Hormone response to glucagon (epinephrine, growth hormne, cortisol)
Secondary Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia
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