Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

Phase 4TerminatedNCT00490893

University Hospital Tuebingen12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus Hypoglycemia

Interventions

DetemirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Tübingen, Medical Department

Tübingen, Germany

Outcomes

Primary Outcomes

Hormone response to hypoglycemia (Glucagon)

Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia

Secondary Outcomes

Hormone response to glucagon (epinephrine, growth hormne, cortisol)

Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia

Data from ClinicalTrials.gov

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