NCT00490893

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
Last Updated

June 25, 2007

Status Verified

June 1, 2007

First QC Date

June 22, 2007

Last Update Submit

June 22, 2007

Conditions

Diabetes MellitusHypoglycemia

Keywords

counterregulationhypoglycemia unawarenessinsulin therapy

Outcome Measures

Primary Outcomes (2)

  • Hormone response to hypoglycemia (Glucagon)

  • Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia

Secondary Outcomes (2)

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

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

Interventions

DetemirDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects male or female
  • Age 18-50 years
  • Female subjects save contraception
  • Ability to take part in the study
  • Signed consent

You may not qualify if:

  • Chronic disease
  • Acute disease during 4 weeks prior to the study
  • Pregnancy
  • Drug treatment other than hormonal contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tübingen, Medical Department

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Andreas Fritsche, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 25, 2007

Study Start

March 1, 2006

Study Completion

December 1, 2006

Last Updated

June 25, 2007

Record last verified: 2007-06

Locations

DE(1)