Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00490893
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Hypoglycemia	Drug: Detemir	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• 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
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. Hormone response to hypoglycemia (Glucagon) []

2. Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia []

Secondary Outcome Measures

1. Hormone response to glucagon (epinephrine, growth hormne, cortisol) []

2. Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Tübingen, Medical Department	Tübingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Andreas Fritsche, MD, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00490893
• Other Study ID Numbers: 2005-003940-79
• First Posted: Jun 25, 2007
• Last Update Posted: Jun 25, 2007
• Last Verified: Jun 1, 2007

• Keywords provided by , ,: counterregulation; hypoglycemia unawareness; insulin therapy
• Additional relevant MeSH terms: Hypoglycemia; Insulin Detemir

Study Results

No Results Posted as of Jun 25, 2007