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Trial registered on ANZCTR


Registration number
ACTRN12616000833460
Ethics application status
Approved
Date submitted
16/06/2016
Date registered
24/06/2016
Date last updated
24/02/2020
Date data sharing statement initially provided
14/01/2019
Date results information initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Real life assessment of SGLT2 inhibitors for type 2 diabetes
Scientific title
Efficacy of SGLT2 inhibitors in a tertiary hospital type 2 diabetes clinic
Secondary ID [1] 289480 0
Nil known
Universal Trial Number (UTN)
U1111-1184-3691
Trial acronym
RMH-SGLT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 299165 0
Condition category
Condition code
Metabolic and Endocrine 299180 299180 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Oral SGLT2 inhibitor, including dapagliflozin, empagliflozin and canagliflozin. The dose and frequency will be determined by the treating clinician as per standard care and will not be defined as part of this study. Each patient will be followed with blood tests and questionnaires at 3 and 6 months after starting SGLT2 inhibitor therapy.
Intervention code [1] 295066 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298661 0
HbA1c by clinically accredited laboratory using EDTA blood sample
Timepoint [1] 298661 0
3 months after starting SGLT2 inhibitor therapy
Secondary outcome [1] 324874 0
HbA1c by clinically accredited laboratory using EDTA blood sample
Timepoint [1] 324874 0
3 and 6 months after starting SGTLTI
Secondary outcome [2] 324896 0
Weight, measured by digital scales
Timepoint [2] 324896 0
3 and 6 months after starting SGLT2I
Secondary outcome [3] 324897 0
Blood pressure by automated sphygmomanometer
Timepoint [3] 324897 0
3 and 6 months after starting SGLT2I
Secondary outcome [4] 324898 0
Blood ketones measured by ambulatory home monitor (Abbott Freestyle Neo)
Timepoint [4] 324898 0
3 and 6 months after starting SGLT2I
Secondary outcome [5] 324899 0
Urine fractional excretion of glucose and electrolytes (change from baseline)
Timepoint [5] 324899 0
3 and 6 months after starting SGLT2I
Secondary outcome [6] 324900 0
Urine albumin/creatinine ratio (change from baseline)
Timepoint [6] 324900 0
3 and 6 months after starting SGLT2I
Secondary outcome [7] 324901 0
Change in number and dose of glucose-lowering and blood pressure-lowering medications from baseline. These data will be obtained through participant interview.
Timepoint [7] 324901 0
3 and 6 months after starting SGLT2I
Secondary outcome [8] 324902 0
Lipid profile, assessed by an accredited laboratory using a serum sample
Timepoint [8] 324902 0
3 and 6 months after starting SGLT2I
Secondary outcome [9] 324903 0
Quality of life, measured using the SF-36 survey
Timepoint [9] 324903 0
3 and 6 months after starting SGLT2I
Secondary outcome [10] 324904 0
Adverse events of interest (genitourinary infection, fracture and hypovolaemia) will be sought during clinician assessment at 3 and 6 months
Timepoint [10] 324904 0
3 and 6 months after starting SGLT2I
Secondary outcome [11] 324982 0
Health utility using the EQ-5D survey
Timepoint [11] 324982 0
3 and 6 months

Eligibility
Key inclusion criteria
Type 2 diabetes according to ADA criteria
No planned changes to glucose-lowering or blood pressure-lowering therapy
Due to commence SGLT2 inhibitor therapy
Willing to comply with therapy, tests and clinical follow-up
Deemed unlikely to require adjustment of blood pressure- or lipid-lowering medication over the next 6 months
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
Use of SGLT2 inhibitor in previous fortnight
Contra-indication to SGLT2 inhibitor therapy, including stage 4 or 5 chronic kidney disease (eGFR<30) and history of genitourinary infection
Presence of a comorbidity that, in the investigators’ opinion, would impair compliance with SGLT2 inhibitor therapy or the study protocol
Pregnancy or desire for pregnancy within the next year
Urinary frequency that may prevent abstinence from urination for the 5-hour period before clinic visits

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analyses will be performed using GraphPad and R software. Grouped and categorical data will be compared by t-test and Fisher’s exact test respectively, and correlations will be performed using the method of Pearson. Multiple regression analyses will be performed using the lm function in R.
To determine if SGLT2 inhibitor therapy is associated with a mean+/-SD reduction in HbA1c of 0.5+/-1.0%, 40 participants need to complete the study to achieve >85% statistical power (alpha=0.05, two-tail). We expect up to 10 patients will withdraw from the study. The final sample size will therefore be 50 participants.

Recruitment
Recruitment status
Completed
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] 5994 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 13419 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 293841 0
Hospital
Name [1] 293841 0
Royal Melbourne Hospital Diabetes and Endocrinology
Address [1] 293841 0
RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
Country [1] 293841 0
Australia
Primary sponsor type
Individual
Name
John Wentworth
Address
RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
Country
Australia
Secondary sponsor category [1] 292678 0
None
Name [1] 292678 0
Address [1] 292678 0
Country [1] 292678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295268 0
Melbourne Health HREC
Ethics committee address [1] 295268 0
RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
Ethics committee country [1] 295268 0
Australia
Date submitted for ethics approval [1] 295268 0
08/04/2016
Approval date [1] 295268 0
06/06/2016
Ethics approval number [1] 295268 0
2016.009

Summary
Brief summary
This study will prospectively assess the clinical effects of SGLT2 inhibitors in people with type 2 diabetes who attend RMH diabetes clinic. The primary aim is to determine their effect on HbA1c after 3 months of therapy. We hypothesise that people who take these drugs will on average lower their HbA1c by 0.5%.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 66730 0
A/Prof John Wentworth
Address 66730 0
RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
Country 66730 0
Australia
Phone 66730 0
+61422992891
Fax 66730 0
+61393470852
Email 66730 0
wentworth@wehi.edu.au
Contact person for public queries
Name 66731 0
A/Prof John Wentworth
Address 66731 0
RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
Country 66731 0
Australia
Phone 66731 0
+61422992891
Fax 66731 0
+61393470852
Email 66731 0
wentworth@wehi.edu.au
Contact person for scientific queries
Name 66732 0
A/Prof John Wentworth
Address 66732 0
RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
Country 66732 0
Australia
Phone 66732 0
+61422992891
Fax 66732 0
+61393470852
Email 66732 0
wentworth@wehi.edu.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?
Clinical and biochemical data
When will data be available (start and end dates)?
31/12/2019 indefinitely
Available to whom?
Any researcher who applies to A/Prof John Wentworth to obtain it.
Available for what types of analyses?
Any approved analyses
How or where can data be obtained?
Email of de-identified excel file
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
We studied 53 people with type 2 diabetes who commenced treatment with a new medication called an SGLT inhibitor. We showed that using this medication improved glucose control and blood pressure, and promoted weight loss of 3kg on average. We sought to determine factors that could predict how well the tablets improved glucose control and showed that the starting glucose levels (measured as HbA1c) and kidney function were the only factors that were predictive. Interestingly, although SGLT inhibitors work by making the body lose glucose in the urine, the extent to which this occurred did not help predict how well these tablets lowered blood glucose levels.