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
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