Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir - Full Text View

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00490893

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Hypoglycemia	Drug: Detemir	Phase IV

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Crossover Assignment, Safety Study
Official Title:	Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Hormone response to hypoglycemia (Glucagon)
Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia

Secondary Outcome Measures:

Hormone response to glucagon (epinephrine, growth hormne, cortisol)
Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia

Enrollment:	12
Study Start Date:	March 2006
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490893

Locations

Germany
University of Tübingen, Medical Department
Tübingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Andreas Fritsche, MD

University Hospital Tuebingen

More Information

Study ID Numbers:	2005-003940-79
Study First Received:	June 22, 2007
Last Updated:	June 22, 2007
ClinicalTrials.gov Identifier:	NCT00490893
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

counterregulation
hypoglycemia unawareness
insulin therapy

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009