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Trial Review
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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
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Scientific title
Efficacy of SGLT2 inhibitors in a tertiary hospital type 2 diabetes clinic
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Secondary ID [1]
289480
0
Nil known
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Universal Trial Number (UTN)
U1111-1184-3691
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Trial acronym
RMH-SGLT2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes
299165
0
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Condition category
Condition code
Metabolic and Endocrine
299180
299180
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
295066
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
298661
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HbA1c by clinically accredited laboratory using EDTA blood sample
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Assessment method [1]
298661
0
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Timepoint [1]
298661
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3 months after starting SGLT2 inhibitor therapy
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Secondary outcome [1]
324874
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HbA1c by clinically accredited laboratory using EDTA blood sample
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Assessment method [1]
324874
0
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Timepoint [1]
324874
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3 and 6 months after starting SGTLTI
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Secondary outcome [2]
324896
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Weight, measured by digital scales
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Assessment method [2]
324896
0
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Timepoint [2]
324896
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3 and 6 months after starting SGLT2I
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Secondary outcome [3]
324897
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Blood pressure by automated sphygmomanometer
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Assessment method [3]
324897
0
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Timepoint [3]
324897
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3 and 6 months after starting SGLT2I
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Secondary outcome [4]
324898
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Blood ketones measured by ambulatory home monitor (Abbott Freestyle Neo)
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Assessment method [4]
324898
0
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Timepoint [4]
324898
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3 and 6 months after starting SGLT2I
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Secondary outcome [5]
324899
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Urine fractional excretion of glucose and electrolytes (change from baseline)
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Assessment method [5]
324899
0
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Timepoint [5]
324899
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3 and 6 months after starting SGLT2I
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Secondary outcome [6]
324900
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Urine albumin/creatinine ratio (change from baseline)
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Assessment method [6]
324900
0
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Timepoint [6]
324900
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3 and 6 months after starting SGLT2I
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Secondary outcome [7]
324901
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Change in number and dose of glucose-lowering and blood pressure-lowering medications from baseline. These data will be obtained through participant interview.
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Assessment method [7]
324901
0
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Timepoint [7]
324901
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3 and 6 months after starting SGLT2I
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Secondary outcome [8]
324902
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Lipid profile, assessed by an accredited laboratory using a serum sample
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Assessment method [8]
324902
0
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Timepoint [8]
324902
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3 and 6 months after starting SGLT2I
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Secondary outcome [9]
324903
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Quality of life, measured using the SF-36 survey
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Assessment method [9]
324903
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Timepoint [9]
324903
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3 and 6 months after starting SGLT2I
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Secondary outcome [10]
324904
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Adverse events of interest (genitourinary infection, fracture and hypovolaemia) will be sought during clinician assessment at 3 and 6 months
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Assessment method [10]
324904
0
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Timepoint [10]
324904
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3 and 6 months after starting SGLT2I
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Secondary outcome [11]
324982
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Health utility using the EQ-5D survey
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Assessment method [11]
324982
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Timepoint [11]
324982
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3 and 6 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2016
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Actual
1/09/2016
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Date of last participant enrolment
Anticipated
30/06/2017
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Actual
30/11/2017
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Date of last data collection
Anticipated
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Actual
4/06/2018
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Sample size
Target
50
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Accrual to date
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Final
53
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
5994
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment postcode(s) [1]
13419
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3050 - Royal Melbourne Hospital
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Funding & Sponsors
Funding source category [1]
293841
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Hospital
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Name [1]
293841
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Royal Melbourne Hospital Diabetes and Endocrinology
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Address [1]
293841
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RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
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Country [1]
293841
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Australia
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Primary sponsor type
Individual
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Name
John Wentworth
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Address
RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
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Country
Australia
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Secondary sponsor category [1]
292678
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None
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Name [1]
292678
0
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Address [1]
292678
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Country [1]
292678
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295268
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Melbourne Health HREC
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Ethics committee address [1]
295268
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RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
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Ethics committee country [1]
295268
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Australia
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Date submitted for ethics approval [1]
295268
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08/04/2016
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Approval date [1]
295268
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06/06/2016
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Ethics approval number [1]
295268
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2016.009
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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%.
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Trial website
None
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Trial related presentations / publications
None
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Public notes
None
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Contacts
Principal investigator
Name
66730
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A/Prof John Wentworth
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Address
66730
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RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
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Country
66730
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Australia
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Phone
66730
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+61422992891
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Fax
66730
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+61393470852
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Email
66730
0
[email protected]
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Contact person for public queries
Name
66731
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A/Prof John Wentworth
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Address
66731
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RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
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Country
66731
0
Australia
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Phone
66731
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+61422992891
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Fax
66731
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+61393470852
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Email
66731
0
[email protected]
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Contact person for scientific queries
Name
66732
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A/Prof John Wentworth
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Address
66732
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RMH Diabetes and Endocrinology
Grattan St
Parkville, Vic 3050
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Country
66732
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Australia
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Phone
66732
0
+61422992891
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Fax
66732
0
+61393470852
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Email
66732
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Clinical and biochemical data
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When will data be available (start and end dates)?
31/12/2019 indefinitely
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Available to whom?
Any researcher who applies to A/Prof John Wentworth to obtain it.
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Available for what types of analyses?
Any approved analyses
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How or where can data be obtained?
Email of de-identified excel file
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
We studied 53 people with type 2 diabetes who comm...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Factors that predict glycaemic response to sodium-glucose linked transporter (SGLT) inhibitors.
2021
https://dx.doi.org/10.1111/imj.14805
N.B. These documents automatically identified may not have been verified by the study sponsor.
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