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Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490893
First Posted: June 25, 2007
Last Update Posted: June 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Official Title: Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00490893     History of Changes
Other Study ID Numbers: 2005-003940-79
First Submitted: June 22, 2007
First Posted: June 25, 2007
Last Update Posted: June 25, 2007
Last Verified: June 2007

Keywords provided by University Hospital Tuebingen:
counterregulation
hypoglycemia unawareness
insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs