Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000333516
Ethics application status
Approved
Date submitted
24/03/2015
Date registered
13/04/2015
Date last updated
16/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel approaches to manage glucocorticoid-induced diabetes in hospital inpatients
Scientific title
The effects of liraglutide vs insulin on glycaemic control in inpatients with glucocorticoid-induced diabetes
Secondary ID [1] 286404 0
Nil known
Universal Trial Number (UTN)
U1111-1168-6022
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
glucocorticoid-induced or -exacerbated diabetes 294559 0
Condition category
Condition code
Metabolic and Endocrine 294867 294867 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Basal insulin (0.2 U/kg by subcutaneous injection in the morning) + liraglutide (0.6 mg by subcutaneous injection in the morning) for 72 h
Intervention code [1] 291474 0
Treatment: Drugs
Comparator / control treatment
Basal insulin (0.2 U/kg by subcutaneous injection in the morning) + short-acting insulin (0.2 U/kg by subcutaneous injection in 3 divided doses before each main meal) for 72 h
Control group
Active

Outcomes
Primary outcome [1] 294618 0
Time spent with normoglycaemia as determined by continuous glucose monitoring
Timepoint [1] 294618 0
72 h
Secondary outcome [1] 313725 0
mean glucose as determined by continuous glucose monitoring
Timepoint [1] 313725 0
72 h
Secondary outcome [2] 313726 0
total daily insulin obtained from drug chart
Timepoint [2] 313726 0
72 h
Secondary outcome [3] 313854 0
peak glucose as determined by continuous glucose monitoring
Timepoint [3] 313854 0
72 h
Secondary outcome [4] 313855 0
glycemic variability as determined by continuous glucose monitoring
Timepoint [4] 313855 0
72 h
Secondary outcome [5] 313856 0
Hypoglycaemia (BGL < 3.5 mmol/L and/or clinical evidence of hypoglycaemia) as determined by continuous glucose monitoring
Timepoint [5] 313856 0
72 h
Secondary outcome [6] 313857 0
Hyperglycaemia (BGL>18 mmol/L) as determined by continuous glucose monitoring
Timepoint [6] 313857 0
72 h

Eligibility
Key inclusion criteria
Glucocorticoid-induced or exacerbated diabetes treated with insulin and/or oral glucose-lowering medication(s)
Glucose >= 15 mmol/l
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes
Admission to intensive care
Likely to require surgical intervention
Likely to be admitted <48 h
eGFR <15 ml/min
Acute vomiting or history of gastroparesis
Known allergy to insulin or GLP-1 agonists
Proliferative retinopathy
Premenopausal females

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
29/05/2014
Actual
29/05/2014
Date of last participant enrolment
Anticipated
Actual
22/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290972 0
Commercial sector/Industry
Name [1] 290972 0
Novo-Nordisk Regional Grant Scheme
Country [1] 290972 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
55 Commercial Rd
Melbourne, Vic, 3004
Country
Australia
Secondary sponsor category [1] 289652 0
None
Name [1] 289652 0
N/A
Address [1] 289652 0
N/A
Country [1] 289652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292567 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 292567 0
Ethics committee country [1] 292567 0
Date submitted for ethics approval [1] 292567 0
Approval date [1] 292567 0
01/04/2014
Ethics approval number [1] 292567 0
75/14

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

Contacts
Principal investigator
Name 55990 0
Prof Leon Bach
Address 55990 0
Department of Endocrinology and Diabetes
The Alfred
55 Commercial Rd
Melbourne Vic 3004
Country 55990 0
Australia
Phone 55990 0
+61 3 9076 2460
Fax 55990 0
Email 55990 0
[email protected]
Contact person for public queries
Name 55991 0
Leon Bach
Address 55991 0
Department of Endocrinology and Diabetes
The Alfred
55 Commercial Rd
Melbourne Vic 3004
Country 55991 0
Australia
Phone 55991 0
+61 3 9076 2460
Fax 55991 0
Email 55991 0
[email protected]
Contact person for scientific queries
Name 55992 0
Leon Bach
Address 55992 0
Department of Endocrinology and Diabetes
The Alfred
55 Commercial Rd
Melbourne Vic 3004
Country 55992 0
Australia
Phone 55992 0
+61 3 9076 2460
Fax 55992 0
Email 55992 0
[email protected]

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.