Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

June 22, 2007 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University of Tübingen, Medical Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hormone response to hypoglycemia (Glucagon)
Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia

Secondary Outcome Measures

Outcome Measure
Hormone response to glucagon (epinephrine, growth hormne, cortisol)
Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 22, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

June 25, 2007

Last Update Submitted That Met QC Criteria

June 22, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-003940-79

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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