Trial Outcomes & Findings for Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia (NCT NCT00353431)

NCT ID: NCT00353431

Last Updated: 2012-05-18

Results Overview

Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: 48 h
• Results posted on: 2012-05-18

Participant Flow

Recruitment Basel 22.01.2007 until 31.08.2008 Recruitment Solothurn 30.12.2006-29.04.2010

Participant milestones

Measure	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.	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.
Overall Study NOT COMPLETED	0	0
Overall Study STARTED	63	67
Overall Study COMPLETED	63	67

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Conventional Insulin Group n=63 Participants 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.	Intensive Insulin Therapy Algorithm n=67 Participants 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 n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Age Continuous	74.22 years STANDARD_DEVIATION 8.77 • n=5 Participants	72.43 years STANDARD_DEVIATION 11.67 • n=7 Participants	73.30 years STANDARD_DEVIATION 10.33 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	38 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment Switzerland	63 participants n=5 Participants	67 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 h

Population: Intension to treat

Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)

Outcome measures

Measure	Conventional Insulin Group n=63 Participants 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.	Intensive Insulin Therapy Algorithm n=67 Participants 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.
Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours	13.0 hours Standard Deviation 14.7	22.5 hours Standard Deviation 10.5

SECONDARY outcome

Timeframe: 24 h

Population: Intension to treat

Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).

Outcome measures

Measure	Conventional Insulin Group n=63 Participants 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.	Intensive Insulin Therapy Algorithm n=67 Participants 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.
Time to Reach the Target Range	24.3 hours Standard Deviation 18.4	11.8 hours Standard Deviation 9.4

SECONDARY outcome

Timeframe: during observation of 48 hours

absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)

Outcome measures

Measure	Conventional Insulin Group n=63 Participants 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.	Intensive Insulin Therapy Algorithm n=67 Participants 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.
Frequency of Hypoglycemia	4 participants	13 participants

SECONDARY outcome

Timeframe: during observation of 48 hours

Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)

Outcome measures

Measure	Conventional Insulin Group n=63 Participants 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.	Intensive Insulin Therapy Algorithm n=67 Participants 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.
Frequency of Severe Hypoglycaemia	0 participants 0	1 participants 0

SECONDARY outcome

Timeframe: during observation of 48 hours

Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)

Outcome measures

Measure	Conventional Insulin Group n=63 Participants 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.	Intensive Insulin Therapy Algorithm n=67 Participants 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.
Frequency of Hypokalaemia	15 participants	15 participants

Adverse Events

Conventional Insulin Group

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Intensive Insulin Therapy Algorithm

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Conventional Insulin Group n=63 participants at risk 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.	Intensive Insulin Therapy Algorithm n=67 participants at risk 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.
Metabolism and nutrition disorders Hypokalemia	23.8% 15/63 • Number of events 15 • 48 h Adverse event as Hypoglycaemia and hypokalemia Serious adverse events were death or immediate risk of death	22.4% 15/67 • Number of events 15 • 48 h Adverse event as Hypoglycaemia and hypokalemia Serious adverse events were death or immediate risk of death
Metabolism and nutrition disorders Hypoglycemia	4.8% 3/63 • Number of events 4 • 48 h Adverse event as Hypoglycaemia and hypokalemia Serious adverse events were death or immediate risk of death	16.4% 11/67 • Number of events 14 • 48 h Adverse event as Hypoglycaemia and hypokalemia Serious adverse events were death or immediate risk of death

Additional Information

Robert Thomann, MD

Intern Medicine Solothurn, Switzerland

Phone: +41326274501

Email: endodiab.bss@bluewin.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place