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

June 22, 2007
June 22, 2007
March 2006
Not Provided
  • Hormone response to hypoglycemia (Glucagon)
  • Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia
Same as current
No Changes Posted
  • Hormone response to glucagon (epinephrine, growth hormne, cortisol)
  • Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia
Same as current
Not Provided
Not Provided
 
Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir
Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
  • Diabetes Mellitus
  • Hypoglycemia
Drug: Detemir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
December 2006
Not Provided

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00490893
2005-003940-79
No
Not Provided
University Hospital Tuebingen
Not Provided
Principal Investigator: Andreas Fritsche, MD University Hospital Tuebingen
University Hospital Tuebingen
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP