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Trial registered on ANZCTR


Registration number
ACTRN12621001102864
Ethics application status
Approved
Date submitted
16/07/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-site study of the effectiveness of Dapagliflozin for diabetic patients admitted to the intensive care unit
Scientific title
Dapagliflozin in Patients with Type-2 Diabetes Admitted to Intensive Care: A Pilot Single-Centre, Feasibility Randomised Controlled Trial
Secondary ID [1] 304775 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 322842 0
Condition category
Condition code
Metabolic and Endocrine 320423 320423 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once daily oral administration of 10mg Dapagliflozin for a maximum of 28 days from the time of enrolment while the participant is admitted to the intensive care unit with adherence of study intervention via audit of hospital medication charts.
Intervention code [1] 321162 0
Treatment: Drugs
Comparator / control treatment
Once daily oral administration of a microcellulose placebo tablet for a maximum of 28 days from the time of enrolment while the participant is admitted to the intensive care unit
Control group
Placebo

Outcomes
Primary outcome [1] 328263 0
Composite outcome of the time-course and magnitude of blood glucose level change.
Timepoint [1] 328263 0
From the time of enrolment until discharge from the intensive care unit obtained via medical record review.
Secondary outcome [1] 398270 0
Incidence of hypoglycaemia defined as a blood glucose level of less than 4 mmol/L.
Timepoint [1] 398270 0
From the time of enrolment until discharge from the intensive care unit as documented in the patient's medical record.
Secondary outcome [2] 398346 0
Total dose of insulin given while admitted to intensive care.
Timepoint [2] 398346 0
Accumulative dose in international units of insulin administered from randomisation until discharge from the ICU or 28-days whichever comes first, as documented in the patient's medical record.
Secondary outcome [3] 398347 0
Mortality at intensive care unit discharge
Timepoint [3] 398347 0
Mortality status at the time of intensive care unit discharged as documented in the patient's medical record.
Secondary outcome [4] 398348 0
Mortality at hospital discharge
Timepoint [4] 398348 0
Mortality status at the time of hospital discharged as documented in the patient's medical record.

Eligibility
Key inclusion criteria
Adult aged 18 years or greater
Expected to be admitted to the ICU until the day after tomorrow
Pre-existing diagnosis of Type-2 diabetes mellitus
Estimated Glomerular Filtration rate (eGFR) of less than 45 ml/min/1.73m2
Able to take medication enterically
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of Type-1 diabetes mellitus (T1DM)
Received an SGLT2 inhibitor within 8 weeks prior to admission to the ICU
Documented SGLT2 inhibitor intolerance
Hepatic impairment with aspartate transaminase [AST] or alanine transaminase [ALT] greater than 3x the upper limit of normal [ULN]; or total bilirubin greater than 2x ULN at time of enrolment
No enteric route for medication administration
Pregnancy
Death is deemed to be imminent or inevitable during this admission
Patients with diabetic ketoacidosis
Pre-existing urinary tract infection
Hypernatraemia defined as a serum sodium levels equal to or greater than 150 mmol/L at the time of screening
Clinician deems enrolment in the study is not in the patient’s best interests

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)
Patients will be randomised via sequentially numbered sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted blocks of variable size, and allocated on a 1:1 basis to either study arm,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data analysis will be performed on an intention-to-treat basis. Summary statistics will be used to describe the clinical data and presented as mean ± SD, median with interquartile range (IQR) or percentages as appropriate. Chi-squared analysis with Fisher’s exact test (when appropriate), and Student’s t-test (Mann Whitney U test for non-normal distributions) will be used to compare data between the active treatment group and the control group with statistical significance declared for probability values of less than 0.05. Analysis of the outcome of excluded patients due to other trials will be in accordance with the CONSORT guidelines.

Recruitment
Recruitment status
Not yet recruiting
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
Recruitment hospital [1] 19972 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 34679 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 309149 0
Hospital
Name [1] 309149 0
Austin Health
Address [1] 309149 0
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 309149 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 310101 0
Individual
Name [1] 310101 0
Professor Rinaldo Bellomo
Address [1] 310101 0
Professor Rinaldo Bellomo
Director, Intensive Care Research
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 310101 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309014 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 309014 0
145 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 309014 0
Australia
Date submitted for ethics approval [1] 309014 0
22/03/2021
Approval date [1] 309014 0
15/07/2021
Ethics approval number [1] 309014 0
HREC/73702/Austin/2021

Summary
Brief summary
Type-2 diabetes (T2DM), a disease of abnormal blood sugar control, is known to contribute to poor immune function, impaired wound healing and increased risk of heart disease, kidney disease and stroke.

When patients who have T2DM are admitted to intensive care they receive a range of routine therapies to support their condition. However, the effectiveness of these current therapies is affected by abnormal blood sugar levels and it would be desirable to restore a normal blood state quickly.

Over the last few years, evidence has emerged that Dapagliflozin, a blood sugar lowering drug that can be administered as a tablet, may help to return blood sugar levels to normal with minimal or no side effects. This drug has also been shown to slow the progression of heart and kidney related complications of diabetes. This makes treatment with Dapagliflozin potentially desirable in patients with T2DM who are admitted to the intensive care unit. However, the effect of Dapagliflozin in such complex and very sick patients has not yet been studied.

For this reason, we are planning to perform a clinical research project, known as a randomised controlled trial. We aim to evaluate whether giving oral Dapagliflozin (10mg daily for up to 28-days while in ICU) compared to placebo (a dummy tablet), normalises blood sugar levels and \ or decreases the need for insulin in 40 patients with T2DM admitted to intensive care.

Importantly, should our findings demonstrate safety and potential benefit, it will allow this treatment to be studied in larger groups and, perhaps become a standard of care for the many patients with T2DM who are admitted to the intensive care unit each year in Australia and potentially worldwide.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 112646 0
Prof Rinaldo Bellomo
Address 112646 0
Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country 112646 0
Australia
Phone 112646 0
+61 3 9496 5992
Fax 112646 0
+61 3 9496 3932
Email 112646 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 112647 0
Prof Rinaldo Bellomo
Address 112647 0
Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country 112647 0
Australia
Phone 112647 0
+61 3 9496 5992
Fax 112647 0
+61 3 9496 3932
Email 112647 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 112648 0
Prof Rinaldo Bellomo
Address 112648 0
Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Country 112648 0
Australia
Phone 112648 0
+61 3 9496 5992
Fax 112648 0
+61 3 9496 3932
Email 112648 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all de-identified individual participant data collected during the trial.
When will data be available (start and end dates)?
Following publication of the primary peer-reviewed manuscript for a period of 2 years.
Available to whom?
Clinician researchers following submission of an ethically approved protocol and formal request.
Available for what types of analyses?
Conformational or hypothesis-generating.
How or where can data be obtained?
Via formal email correspondence with the chief investigator, Prof Rinaldo Bellomo; E: rinaldo.bellomo@austin.org.au
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 12543 0
Study protocol
Citation [1] 12543 0
Link [1] 12543 0
Email [1] 12543 0
rinaldo.bellomo@austin.org.au
Other [1] 12543 0
Attachment [1] 12543 0
Summary results
No Results