An interventional study of Novorapid ®, Novo Nordisk, Denmark in Hyperglycemias, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-18.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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)
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.
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's enrollment of 130 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Novorapid ®, Novo Nordisk, Denmark
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.
Drug: Novorapid ®, Novo Nordisk, Denmark
Comparison of a sliding scale with an intensive s.c. scale
Also known as: insulin aspart,, Novolog
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)
Time frame: 48 h
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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: during observation of 48 hours
Recruitment Basel 22.01.2007 until 31.08.2008 Recruitment Solothurn 30.12.2006-29.04.2010
| Milestone | Conventional Insulin Group | Intensive Insulin Therapy Algorithm |
|---|---|---|
| Started | 63 | 67 |
| Completed | 63 | 67 |
| Not completed | 0 | 0 |
Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)
| hours | Conventional Insulin Group | Intensive Insulin Therapy Algorithm |
|---|---|---|
| Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours | 13.0 ± 14.7 | 22.5 ± 10.5 |
Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).
| hours | Conventional Insulin Group | Intensive Insulin Therapy Algorithm |
|---|---|---|
| Time to Reach the Target Range | 24.3 ± 18.4 | 11.8 ± 9.4 |
absolute number of participants with hypoglycemia (plasma glucose \< 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)
| participants | Conventional Insulin Group | Intensive Insulin Therapy Algorithm |
|---|---|---|
| Frequency of Hypoglycemia | 4 | 13 |
Number of participants with severe hypoglycaemia (plasma glucose \< 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)
| participants | Conventional Insulin Group | Intensive Insulin Therapy Algorithm |
|---|---|---|
| Frequency of Severe Hypoglycaemia | 0 ± 0 | 1 ± 0 |
Number of participants with hypokalaemia (potassium \< 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)
| participants | Conventional Insulin Group | Intensive Insulin Therapy Algorithm |
|---|---|---|
| Frequency of Hypokalaemia | 15 | 15 |
Collected over 48 h. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Insulin Group | — | 0/63 (0%) | 18/63 (28.6%) |
| Intensive Insulin Therapy Algorithm | — | 0/67 (0%) | 26/67 (38.8%) |
| Event | Conventional Insulin Group | Intensive Insulin Therapy Algorithm |
|---|---|---|
| HypokalemiaMetabolism and nutrition disorders | 15/63 | 15/67 |
| HypoglycemiaMetabolism and nutrition disorders | 3/63 | 11/67 |
| Age, Categorical(Participants) | Conventional Insulin Group | Intensive Insulin Therapy Algorithm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 15 | 26 |
| >=65 years | 52 | 52 | 104 |
| Age Continuous(years) | Conventional Insulin Group | Intensive Insulin Therapy Algorithm | Total |
|---|---|---|---|
| Mean | 74.22 ± 8.77 | 72.43 ± 11.67 | 73.30 ± 10.33 |
| Sex: Female, Male(Participants) | Conventional Insulin Group | Intensive Insulin Therapy Algorithm | Total |
|---|---|---|---|
| Female | 34 | 29 | 63 |
| Male | 29 | 38 | 67 |
| Region of Enrollment(participants) | Conventional Insulin Group | Intensive Insulin Therapy Algorithm | Total |
|---|---|---|---|
| Switzerland | 63 | 67 | 130 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland