HyperglycemiasNCT00353431
Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
A study testing Novorapid ®, Novo Nordisk, Denmark in people with Hyperglycemias, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemias
- What is being tested?
- Novorapid ®, Novo Nordisk, Denmark
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2006to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients with hyperglycaemia (≥ 8.0 mmol/l) admitted to the medical emergency room.
- patients with presumed hospitalisation in ER or medical ward of more than 48 h duration.
Who cannot join
- patients in shock (defined as hypotension or shock index > 1 with oliguria, changed mental status and metabolic acidosis)
- patients with a terminal illness on palliative care
- patients with type 1 diabetes
- patients with insulin pump therapy
- patients with need for hospitalisation in the intensive or coronary care unit.
- patients with presumed hospitalisation shorter than 48 hours
- known pregnancy (in women with childbearing potential pregnancy test for exclusion mandatory)
- no informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine,
Basel, Canton of Basel-City, 4031
About this study
The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l)
Read the detailed description
BACKGROUND: Prospective randomized trials have shown that near-normoglycemic blood glucose control using insulin infusions achieves a significant reduction in mortality of severely ill patients in intensive care units, of patients with acute myocardial infarction and with stroke. This implies that most severely ill patients with hyperglycemia should be treated with insulin to reach near-normoglycemia. However, this is not common practice today in emergency room admissions outside the intensive care unit, and strategies to achieve near-normoglycemia safely outside the ICU setting with s.c. injections (insulin infusions are too risky outside the ICU) have not been established.
AIM: To evaluate an insulin therapy algorithm using s.c. injections which permits effective and safe glycemic management of emergency room patients with hyperglycemia.
DESIGN: Randomized, controlled trial with an open intervention. Patients presenting with hyperglycemia on admission to the emergency room are randomized 1:1 either to conventional treatment (conventional insulin group) or to intensive treatment (intensive insulin group).
METHODS: 140 patients admitted to the medical emergency rooms of the University Hospital Basel and the Regional Hospital of Solothurn will be included and randomized as described above. All patients with plasma glucose levels exceeding 8.0 mmol/l will be included.
Exclusion criteria include severely immunocompromised patients, patients in shock, patients with terminal illnesses on palliative care, type 1 diabetes with or without ketoacidosis and patients which require intensive care unit (ICU) or cardial care unit (CCU) therapy.
PRIMARY ENDPOINT: Time in the glycaemic target range (5.5-7.0 mmol/l) during the period of observation of 48 hours (expected to be longer in the intensive insulin group)
SECONDARY ENDPOINTS: Time to reach the target range. Frequency of hypoglycaemia (plasma glucose < 3.8 mmol/l). Frequency of severe hypoglycaemia (plasma glucose < 2.5 mmol/l. Frequency of hypokalaemia.
- Conditions
- Hyperglycemias
- Being tested
- Novorapid ®, Novo Nordisk, Denmark
- Keywords
- Hyperglycaemia, algorithm, emergency, s.c. insulin therapy, Emergency patient
- Medical subject headings
- Hyperglycemia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novorapid ®, Novo Nordisk, DenmarkDrug
Also called insulin aspart,, Novolog
Comparison of a sliding scale with an intensive s.c. scale
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Conventional insulin group:
In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician. Receives: Drug: Novorapid ®, Novo Nordisk, Denmark |
| 2 | Experimental | Intensive insulin therapy algorithm:
The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake. Receives: Drug: Novorapid ®, Novo Nordisk, Denmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours
Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)
Measured: 48 h
Secondary outcomes (4)
Time to Reach the Target Range
Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).
Measured: 24 h
Frequency of Hypoglycemia
absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)
Measured: during observation of 48 hours
Frequency of Severe Hypoglycaemia
Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)
Measured: during observation of 48 hours
Frequency of Hypokalaemia
Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)
Measured: during observation of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startDec 2006
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperglycemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Keller, MD, Prof, Principal investigator, Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353431
- Sponsor's protocol ID
- EKBB13/06
- Other IDs
- ISRCTN55224894
- Status last verified
- May 2012
- First submitted
- 17 Jul 2006
- Last updated
- 18 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
- ClinicalTrials.gov ID
- NCT00353431
- Acronym / sponsor ID
- EKBB13/06
- Conditions
- Hyperglycemias
- Keywords
- Hyperglycaemia, algorithm, emergency, s.c. insulin therapy, Emergency patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Jul 2006 (estimated)
- Results
- Posted 8 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l)
Detailed description
BACKGROUND: Prospective randomized trials have shown that near-normoglycemic blood glucose control using insulin infusions achieves a significant reduction in mortality of severely ill patients in intensive care units, of patients with acute myocardial infarction and with stroke. This implies that most severely ill patients with hyperglycemia should be treated with insulin to reach near-normoglycemia. However, this is not common practice today in emergency room admissions outside the intensive care unit, and strategies to achieve near-normoglycemia safely outside the ICU setting with s.c. injections (insulin infusions are too risky outside the ICU) have not been established.
AIM: To evaluate an insulin therapy algorithm using s.c. injections which permits effective and safe glycemic management of emergency room patients with hyperglycemia.
DESIGN: Randomized, controlled trial with an open intervention. Patients presenting with hyperglycemia on admission to the emergency room are randomized 1:1 either to conventional treatment (conventional insulin group) or to intensive treatment (intensive insulin group).
METHODS: 140 patients admitted to the medical emergency rooms of the University Hospital Basel and the Regional Hospital of Solothurn will be included and randomized as described above. All patients with plasma glucose levels exceeding 8.0 mmol/l will be included.
Exclusion criteria include severely immunocompromised patients, patients in shock, patients with terminal illnesses on palliative care, type 1 diabetes with or without ketoacidosis and patients which require intensive care unit (ICU) or cardial care unit (CCU) therapy.
PRIMARY ENDPOINT: Time in the glycaemic target range (5.5-7.0 mmol/l) during the period of observation of 48 hours (expected to be longer in the intensive insulin group)
SECONDARY ENDPOINTS: Time to reach the target range. Frequency of hypoglycaemia (plasma glucose < 3.8 mmol/l). Frequency of severe hypoglycaemia (plasma glucose < 2.5 mmol/l. Frequency of hypokalaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Novorapid ®, Novo Nordisk, DenmarkConventional insulin group: In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician. |
| 2 | Experimental | Drug: Novorapid ®, Novo Nordisk, DenmarkIntensive insulin therapy algorithm: The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients with hyperglycaemia (≥ 8.0 mmol/l) admitted to the medical emergency room.
- patients with presumed hospitalisation in ER or medical ward of more than 48 h duration.
Key exclusion criteria (8 listed)
- patients in shock (defined as hypotension or shock index > 1 with oliguria, changed mental status and metabolic acidosis)
- patients with a terminal illness on palliative care
- patients with type 1 diabetes
- patients with insulin pump therapy
- patients with need for hospitalisation in the intensive or coronary care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novorapid ®, Novo Nordisk, DenmarkAlso: insulin aspart,, NovologComparison of a sliding scale with an intensive s.c. scale | Drug | 1, 2 |
Primary outcome
Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours
Time frame: 48 h
Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)
4 secondary outcomes
Time to Reach the Target Range
Time frame: 24 h
Frequency of Hypoglycemia
Time frame: during observation of 48 hours
Frequency of Severe Hypoglycaemia
Time frame: during observation of 48 hours
Frequency of Hypokalaemia
Time frame: during observation of 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Keller, MD, Prof principal investigator
Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novorapid ®, Novo Nordisk, Denmark in people with Hyperglycemias, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours (time frame: 48 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012; AzTrials last refreshed its copy on 31 Oct 2026.