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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 290972 0
Level 3
21 Solent Circuit
BAULKHAM HILLS NSW 2153
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
High dose steroids can raise blood glucose levels. These can cause infections, prolong hospital stay and even rarely result in death. Little is known about the best way to manage patients with ‘steroid diabetes’. We will study various approaches to manage high glucose levels in patients treated with steroids in hospital. We will use minimally invasive continuous glucose monitoring, a contemporary technology, to compare and evaluate in detail two different treatment schedules. One intervention will combine longer acting and mealtime insulin (conventional regimen), and the other will combine liraglutide, a newer non-insulin injection, together with longer acting insulin. The results of this study will provide important objective pilot data on management of patients with ‘steroid diabetes’ in hospital.
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
leon.bach@monash.edu
Contact person for public queries
Name 55991 0
Prof 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
leon.bach@monash.edu
Contact person for scientific queries
Name 55992 0
Prof 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
leon.bach@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results