ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000016336

Ethics application status

Approved

Date submitted

21/12/2016

Date registered

5/01/2017

Date last updated

24/02/2020

Date data sharing statement initially provided

15/01/2019

Date results provided

15/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Does empagliflozin preserve pancreas function in recently-diagnosed type 1 diabetes?

Scientific title

Feasibility and safety of SGLT2 inhibition by empagliflozin for the preservation of pancreas function in recent-onset type 1 diabetes.

Secondary ID [1]

SGLT-T1D

Universal Trial Number (UTN)

Trial acronym

n/a

Linked study record

n/a

Health condition

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

type 1 diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Empagliflozin 25mg orally daily for 6 months. Compliance will be monitored by assessing drug packets returned.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No comparator - safety and feasibility study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Protocol compliance, measured by the frequency of deviation from the study protocol. Deviations will be assessed by pill counts at monthly visits and by reviewing visit data, collected monthly for the first 3 months and then 6-weekly up to 9 months after starting study drug.

Timepoint [1]

9 months after starting study drug.

Secondary outcome [1]

Number and severity of adverse events.
Adverse events will be reported directly to the medical monitor by email or telephone. The severity will be graded 1, 2, 3, 4 and 5 respectively for mild, moderate, severe and undesirable, life-threatening and disabling, and fatal events. Attribution will be assigned as follows:
1. Unrelated: The adverse event is clearly not related to empagliflozin.
2. Unlikely: The adverse event is doubtfully related to empagliflozin.
3. Possible: The adverse event may be related to empagliflozin.
4. Probable: The adverse event is likely related to empagliflozin.
5. Definite: The adverse event is clearly related to empagliflozin.

Timepoint [1]

9 months after starting study drug.

Secondary outcome [2]

Participant quality of life and diabetes distress, assessed using SF-36 and DDS-17 questionnaires (composite outcome).

Timepoint [2]

3, 6 and 9 months after starting study drug.

Secondary outcome [3]

Beta cell function, defined as the C-peptide area under the curve (AUC) for two hours following a liquid meal. Serum C-peptide will be measured by Royal Melbourne Hospital Biochemistry Laboratory.

Timepoint [3]

The C-peptide AUC will be calculated from results obtained at -10, -5, 15, 30, 60, 90 and 120 minutes after the mixed meal. The C-peptide AUC will be calculated at 3, 6 and 9 months after starting study drug.

Secondary outcome [4]

Glycaemic variability, measured using a masked iPro subcutaneous continuous glucose monitor, worn for 96 hours.

Timepoint [4]

3, 6 and 9 months after starting study drug.

Secondary outcome [5]

HbA1c measured by Melbourne Health Pathology

Timepoint [5]

3, 6 and 9 months after starting study drug.

Secondary outcome [6]

Systolic and diastolic blood pressure, measured using an automated sphygmomanometer.

Timepoint [6]

3, 6 and 9 months after starting study drug.

Secondary outcome [7]

Body weight and body composition, measured using Tanita BC-601 impedance scales (composite outcome).

Timepoint [7]

3, 6 and 9 months after starting study drug.

Eligibility

Key inclusion criteria

Age between 18 and 40 years at time of consent
Type 1 diabetes diagnosed within 100 days of the month 0 visit with antibodies against at least one of the GAD, IA2, ZnT8 or insulin antigens, measured by an accredited clinical laboratory
Demonstrated ability to comply with insulin prescription and to record home glucose readings at least four times a day
A meal-stimulated C-peptide >0.07nmol/l (>0.2ng/ml)

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Contra-indication to empagliflozin
Serious co-morbidity deemed by the study clinician to pose unacceptable risk
Unwilling to accept the rigors of the study, including four meal tolerance tests and frequent sustained periods of home glucose and ketone monitoring
If female: pregnancy, breast feeding or a desire for pregnancy during the study
If female with reproductive potential, refusal to use contraception during the study

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

n/a

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

n/a

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

nil

Phase

Phase 2

Type of endpoint/s

Safety

Statistical methods / analysis

Missing data, where appropriate, will be filled by multiple imputation. Descriptive statistics will be used to describe baseline characteristics of study cohort and report protocol compliance and adverse events. Changes in beta-cell function over time will be analysed using Friedman test while Wilcoxon sign-rank test will be used to assess overall change. P<0.05 will be considered significant.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2017

Actual

1/03/2017

Date of last participant enrolment

Anticipated

30/06/2018

Actual

28/08/2018

Date of last data collection

Anticipated

30/06/2019

Actual

20/05/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Melbourne Hospital

Address [1]

Grattan St
Parkville, VIC, 3050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Melbourne Health

Address

Research Directorate
Royal Melbourne Hospital
Grattan St
Parkville, VIC, 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health HREC

Ethics committee address [1]

Royal Melbourne Hospital
Grattan St
Parkville, VIC, 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2016

Approval date [1]

20/12/2016

Ethics approval number [1]

2016.367

Summary

Brief summary

Empagliflozin is used to treat type 2 diabetes. It works by promoting loss of glucose in the urine. Recent evidence suggests this drug might help preserve pancreas function in people with diabetes. This study will assess the feasibility and safety of this approach in people who are within 100 days of being diagnosed with type 1 diabetes.

Trial website

n/a

Trial related presentations / publications

n/a

Public notes

n/a

Contacts

Principal investigator

Name

A/Prof John Wentworth

Address

Diabetes and Endocrinology
Royal Melbourne Hospital
Grattan St
Parkville, VIC, 3050

Country

Australia

Phone

+61 3 93427000

Fax

+61 3 93470852

[email protected]

Contact person for public queries

Name

John Wentworth

Address

Diabetes and Endocrinology
Royal Melbourne Hospital
Grattan St
Parkville, VIC, 3050

Country

Australia

Phone

+61 3 93427000

Fax

+61 3 93470852

[email protected]

Contact person for scientific queries

Name

John Wentworth

Address

Diabetes and Endocrinology
Royal Melbourne Hospital
Grattan St
Parkville, VIC, 3050

Country

Australia

Phone

+61 3 93427000

Fax

+61 3 93470852

[email protected]

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 clinical and biochemical data from the trial

When will data be available (start and end dates)?

31/12/2019 indefinitely

Available to whom?

Any researcher, on application to A/Prof John Wentworth

Available for what types of analyses?

Any

How or where can data be obtained?

Email of de-identified excel spreadsheet

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

Source	Title	Year of Publication	DOI
Dimensions AI	A pilot study of the feasibility of empagliflozin in recent-onset type 1 diabetes	2020	https://doi.org/10.1016/j.metop.2020.100021

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically