Subcutaneous insulin therapy of hyperglycemia after initiation of oral intake in the ICU

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002773-30-AT

Enrollment

Registered

2007-08-17

Start date

2007-10-15

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia is very common in hospitalized, critically ill patients and is associated with higher mortality and morbidity. Careful monitoring and therapy of hyperglycemia have become standard in the ICU. Therapy of hyperglycemia by subcutaneously applied insulin after initiation of oral intake in the ICU is going to be investigated. MedDRA version: 9.1 Level: LLT Classification code 10042216 Term: Stress induced hyperglycemia

Interventions

Trade Name: NovoRapid Product Name: NovoRapid Pharmaceutical Form: Injection* INN or Proposed INN: INSULIN ASPART CAS Number: 116094236 Concentration unit: IU international unit(s) Trade Name: Levemi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients between 18 and 90 years old, admitted to our ICU and requiring treatment with insulin (fasting blood glucose > 125 mg/dl) after initiation of oral intake in the ICU. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients -being pregnant at ICU-admission -with Glasgow-Coma-Scale < 12 - having had a lung- or hearttransplantation

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether subcutaneous Insulin therapy, consisting of prandial Insulin (NovoRapid, Novo Nordisk) and basis insulin (Levemir, Novo Nordisk) leads to a better control of hyperglycemia with less variability of blood glucose concentration in ciritcally ill patients in the ICU after initiation of oral intake compared to continuous infusion of Insulin (NovoRapid, Novo Nordisk).;Secondary Objective: Comparison of occurrence of hypoglycemia (blood glucose < 40 mg/dl). nursing work load and nursing satisfaction.;Primary end point(s): Comparison of glycemic control between the two patientgroups, of which one received subcutaneously applied Insulin (prandial insulin and basis insulin) and the other received intravenously applied insulininfusion. The AUC (area under the curve) of glucose concentrations outside of target concentration from 100 to 125 mg/dl will be compared between these two groups.	—

Measure

Time frame

Main Objective: To determine whether subcutaneous Insulin therapy, consisting of prandial Insulin (NovoRapid, Novo Nordisk) and basis insulin (Levemir, Novo Nordisk) leads to a better control of hyperglycemia with less variability of blood glucose concentration in ciritcally ill patients in the ICU after initiation of oral intake compared to continuous infusion of Insulin (NovoRapid, Novo Nordisk).;Secondary Objective: Comparison of occurrence of hypoglycemia (blood glucose < 40 mg/dl). nursing work load and nursing satisfaction.;Primary end point(s): Comparison of glycemic control between the two patientgroups, of which one received subcutaneously applied Insulin (prandial insulin and basis insulin) and the other received intravenously applied insulininfusion. The AUC (area under the curve) of glucose concentrations outside of target concentration from 100 to 125 mg/dl will be compared between these two groups.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026