Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/07/2006
Date assigned
17/08/2006
Last edited
23/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulrich Keller

ORCID ID

Contact details

Petersgraben 4
Basel
4031
Switzerland
+41 (0)612 655 078
ukeller@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00353431

Protocol/serial number

EKBB13/06

Study information

Scientific title

Evaluation of an algorithm for intensive subcutaneous insulin therapy in emergency room patients with hyperglycaemia

Acronym

Euglycemia

Study hypothesis

Time in the glycaemic target range (5.5 to 7.0 mmol/l) during the period of observation of 48 hours expected to be longer in the intensive insulin group.

Ethics approval

Local Ethics Committee of Basel, Switzerland (EKBB) approval, 20/03/2006, ref: 13/06

Study design

Interventional randomised open-label active-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

All medical patients with a plasma glucose concentration more than 8 mmol/l

Intervention

Comparison of a normal sliding scale with subcutaneous (s.c.) insulin injections versuss the new algorithm with s.c. insulin injections (in both groups NovoRapid ®)

Intervention type

Drug

Phase

Not Applicable

Drug names

Subcutaneous insulin

Primary outcome measures

Time in the glycaemic target range (5.5 to 7.0 mmol/l) during the period of observation of 48 hours (expected to be longer in the intensive insulin group).

Secondary outcome measures

1. Time to reach the target range (expected to be shorter in the
intensive insulin group)
2. Frequency of hypoglycaemia (plasma glucose less than 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)
3. Frequency of severe hypoglycaemia (plasma glucose less than 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)
4. Frequency of hypokalaemia (safety endpoint, expected to be similar in the two groups)

Overall trial start date

31/08/2006

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients with hyperglycaemia (more than 8.0 mmol/l) admitted to the medical emergency room
2. Patients with presumed hospitalisation in the Emergency Room (ER) or medical ward of more than 48 hours duration

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Patients in shock (defined as hypotension or shock index more than one with oliguria, changed mental status and metabolic acidosis)
2. Patients with a terminal illness on palliative care
3. Patients with type one diabetes
4. Patients with insulin pump therapy
5. Patients with need for hospitalisation in the intensive or coronary care unit
6. Patients with presumed hospitalisation shorter than 48 hours
7. Known pregnancy (in women of birthbearing age pregnancy test for exclusion mandatory)
8. No informed consent

Recruitment start date

31/08/2006

Recruitment end date

30/04/2008

Locations

Countries of recruitment

Switzerland

Trial participating centre

Petersgraben 4
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital of Basel (Switzerland)

Sponsor details

Petersgraben 4
Basel
4031
Switzerland
+41 (0)612 655 078
ukeller@uhbs.ch

Sponsor type

University/education

Website

http://www.endo-diabasel.ch

Funders

Funder type

Industry

Funder name

Novo Nordisk (Switzerland)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Denmark

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00353431

Publication summary

Publication citations

Additional files

Editorial Notes