Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

Phase 4

Terminated

• Conditions: Diabetes Mellitus; Hypoglycemia

• Registration Number: NCT00490893
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study Completion: 2006-12
• Status Verified: 2007-06
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-22
• Last Update Submitted: 2007-06-22
• Study First Posted: 2007-06-25
• Last Update Posted: 2007-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Hormone response to hypoglycemia (Glucagon)
Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Tübingen, Medical Department; 🇩🇪 Tübingen, Germany