Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000402347
Ethics application status
Approved
Date submitted
25/06/2008
Date registered
13/08/2008
Date last updated
13/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study of Intensive Supplemental Insulin Therapy: Novorapid vs Actrapid
Scientific title
A Pilot Study of the Safety and Efficacy of Intensive Supplemental Insulin Therapy with Novorapid vs Actrapid in people with diabetes
Secondary ID [1] 664 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 3315 0
Condition category
Condition code
Metabolic and Endocrine 3662 3662 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to achieve tight glycaemic control with supplemental subcutaneous insulin, either Novorapid, or Actrapid. For subjects randomised to Novorapid, they will receive supplemental Novorapid if their glucose level is >8 mmol/L at a standard testing time (before meals/after meals/2200), in accordance with an algorithm which takes into consideration the subject's weight, glucose level and time of day. Subjects randomised to Actrapid will be administered supplemental insulin if their glucose level is >10 mmol/L, in accordance with a similar algorithm. The intervention will continue until discharge, or the occurence of an event which mandates withdrawal (eg becomes nil by mouth, insulin infusion commenced). This is a hospital based intervention only.
Intervention code [1] 3054 0
Treatment: Drugs
Comparator / control treatment
This is a comparison of 2 active treatments to determine which gives the greatest efficacy with the fewest complications.
Control group
Active

Outcomes
Primary outcome [1] 4377 0
Frequency of mild (blood glucose 3-4 mmol/L), severe (blood glucose level <3 mmol/L) and all hypoglycaemic episodes during the period of the person's participation in the trial
Timepoint [1] 4377 0
This will be assessed over the entire period of the person's involvement in the trial, and determined on the basis of blood glucose measurements by fingerprick performed at standard times before and after meals, bedtime and 0200-0300.
Primary outcome [2] 4378 0
Frequency of mild (blood glucose level (BGL) >12 mmol/L), severe (blood glucose level >16 mmol/L) and total hyperglycaemia
Timepoint [2] 4378 0
This will be assessed over the entire period of the person's involvement in the trial, and determined on the basis of blood glucose measurements by fingerprick performed at standard times before and after meals, bedtime and 0200-0300.
Primary outcome [3] 4379 0
Mean BGL over the Mandatory testing times
Timepoint [3] 4379 0
This will be assessed over the entire period of the person's involvement in the trial, and determined on the basis of blood glucose measurements by fingerprick performed at standard times before and after meals, bedtime and 0200-0300.
Secondary outcome [1] 7385 0
nil
Timepoint [1] 7385 0
n/a

Eligibility
Key inclusion criteria
diabetes
on oral agents or insulin
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnant
ketoacidosis
nil by mouth

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3518 0
Self funded/Unfunded
Name [1] 3518 0
Country [1] 3518 0
Primary sponsor type
Individual
Name
NW Cheung
Address
Dept of Diabetes & Endocrinology
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 3158 0
None
Name [1] 3158 0
Address [1] 3158 0
Country [1] 3158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5555 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 5555 0
Ethics committee country [1] 5555 0
Australia
Date submitted for ethics approval [1] 5555 0
30/06/2005
Approval date [1] 5555 0
12/12/2005
Ethics approval number [1] 5555 0
2005/8/4.7(2155)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28701 0
Address 28701 0
Country 28701 0
Phone 28701 0
Fax 28701 0
Email 28701 0
Contact person for public queries
Name 11858 0
NW Cheung
Address 11858 0
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country 11858 0
Australia
Phone 11858 0
02 98455555
Fax 11858 0
Email 11858 0
wah@westgate.wh.usyd.edu.au
Contact person for scientific queries
Name 2786 0
NW Cheung
Address 2786 0
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country 2786 0
Australia
Phone 2786 0
02 98455555
Fax 2786 0
Email 2786 0
wah@westgate.wh.usyd.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.