Diabetes Mellitus, Hypoglycemia
Conditions
Keywords
counterregulation, hypoglycemia unawareness, insulin therapy
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.
Interventions
DRUGDetemir
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hormone response to hypoglycemia (Glucagon) | — |
| Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia | — |
Secondary
| Measure | Time frame |
|---|---|
| Hormone response to glucagon (epinephrine, growth hormne, cortisol) | — |
| Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia | — |
Countries
Germany
Outcome results
None listed