NCT00467246

Brief Summary

Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
Last Updated

April 30, 2007

Status Verified

April 1, 2007

First QC Date

April 27, 2007

Last Update Submit

April 27, 2007

Conditions

Diabetes Mellitus

Keywords

Diabetes emergencies

Outcome Measures

Primary Outcomes (2)

  • Time to normoglycaemia

  • Reduction of recurrence of ketoacidosis and hyperglycaemia.

Secondary Outcomes (1)

  • To investigate time to treatment in patients presenting with a hyperglycaemic emergency

Interventions

LevemirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with a diabetic emergency aged 18 and above.

You may not qualify if:

  • Patients who do not speak English and need a translator.
  • Patients under the age of 18 years.
  • Patients who are unable to give their consent and who do not have a relative present wiling to give assent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

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

  • David Kerr, MD

    Royal Bournemouth Hospital

    PRINCIPAL INVESTIGATOR

  • Martin Taylor, MD

    Royal Bournemouth Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Last Updated

April 30, 2007

Record last verified: 2007-04