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Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

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ClinicalTrials.gov Identifier: NCT00353431
Recruitment Status : Completed
First Posted : July 18, 2006
Results First Posted : May 8, 2012
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hyperglycemias
Intervention Drug: Novorapid ®, Novo Nordisk, Denmark
Enrollment 130
Recruitment Details Recruitment Basel 22.01.2007 until 31.08.2008 Recruitment Solothurn 30.12.2006-29.04.2010
Pre-assignment Details  
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 63 67
Completed 63 67
Not Completed 0 0
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 63 67 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 67 participants 130 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  17.5%
15
  22.4%
26
  20.0%
>=65 years
52
  82.5%
52
  77.6%
104
  80.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 67 participants 130 participants
74.22  (8.77) 72.43  (11.67) 73.30  (10.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 67 participants 130 participants
Female
34
  54.0%
29
  43.3%
63
  48.5%
Male
29
  46.0%
38
  56.7%
67
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 63 participants 67 participants 130 participants
63 67 130
1.Primary Outcome
Title Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intension to treat
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 63 67
Mean (Standard Deviation)
Unit of Measure: hours
13.0  (14.7) 22.5  (10.5)
2.Secondary Outcome
Title Time to Reach the Target Range
Hide Description Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).
Time Frame 24 h
Hide Outcome Measure Data
Hide Analysis Population Description
Intension to treat
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 63 67
Mean (Standard Deviation)
Unit of Measure: hours
24.3  (18.4) 11.8  (9.4)
3.Secondary Outcome
Title Frequency of Hypoglycemia
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 63 67
Measure Type: Number
Unit of Measure: participants
4 13
4.Secondary Outcome
Title Frequency of Severe Hypoglycaemia
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 63 67
Measure Type: Number
Unit of Measure: participants
0 1
5.Secondary Outcome
Title Frequency of Hypokalaemia
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 63 67
Measure Type: Number
Unit of Measure: participants
15 15
Time Frame 48 h
Adverse Event Reporting Description Adverse event as Hypoglycaemia and hypokalemia Serious adverse events were death or immediate risk of death
 
Arm/Group Title Conventional Insulin Group Intensive Insulin Therapy Algorithm
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Conventional Insulin Group Intensive Insulin Therapy Algorithm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Insulin Group Intensive Insulin Therapy Algorithm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/63 (0.00%)      0/67 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conventional Insulin Group Intensive Insulin Therapy Algorithm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/63 (28.57%)      26/67 (38.81%)    
Metabolism and nutrition disorders     
Hypokalemia  [1]  15/63 (23.81%)  15 15/67 (22.39%)  15
Hypoglycemia  [2]  3/63 (4.76%)  4 11/67 (16.42%)  14
Indicates events were collected by systematic assessment
[1]
Blood samples at admission, day 1 und day 2
[2]
Blood glucose measurements according the protocol
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Thomann, MD
Organization: Intern Medicine Solothurn, Switzerland
Phone: +41326274501
EMail: endodiab.bss@bluewin.ch
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00353431     History of Changes
Other Study ID Numbers: EKBB13/06
ISRCTN55224894 ( Registry Identifier: Current Controlled Trials Database )
First Submitted: July 17, 2006
First Posted: July 18, 2006
Results First Submitted: October 31, 2011
Results First Posted: May 8, 2012
Last Update Posted: May 18, 2012