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Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

This study has been terminated.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00490893
First received: June 22, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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:

U.S. FDA Resources

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

No publications provided

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

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013