ANZCTR - Registration

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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

15/06/2022

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Composite outcome of the time-course and magnitude of blood glucose level change.

Timepoint [1]

From the time of enrolment until discharge from the intensive care unit obtained via medical record review.

Secondary outcome [1]

Incidence of hypoglycaemia defined as a blood glucose level of less than 4 mmol/L.

Timepoint [1]

From the time of enrolment until discharge from the intensive care unit as documented in the patient's medical record.

Secondary outcome [2]

Total dose of insulin given while admitted to intensive care.

Timepoint [2]

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]

Mortality at intensive care unit discharge

Timepoint [3]

Mortality status at the time of intensive care unit discharged as documented in the patient's medical record.

Secondary outcome [4]

Mortality at hospital discharge

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Diagnosis of Type-1 diabetes mellitus (T1DM)
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

Recruiting

Date of first participant enrolment

Anticipated

1/08/2022

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

145 Studley Road
Heidelberg
Victoria 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo

Address [1]

Professor Rinaldo Bellomo
Director, Intensive Care Research
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Road
Heidelberg
Victoria 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/03/2021

Approval date [1]

15/07/2021

Ethics approval number [1]

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

Prof Rinaldo Bellomo

Address

Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Rinaldo Bellomo

Address

Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

rinaldo.bellomo@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12543	Study protocol			rinaldo.bellomo@austin.org.au

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.

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