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Trial registered on ANZCTR


Registration number
ACTRN12624000448549
Ethics application status
Approved
Date submitted
12/03/2024
Date registered
12/04/2024
Date last updated
12/04/2024
Date data sharing statement initially provided
12/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor
Scientific title
Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor (PARTNER)
Secondary ID [1] 311659 0
None
Universal Trial Number (UTN)
Trial acronym
PARTNER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 333117 0
Condition category
Condition code
Metabolic and Endocrine 329808 329808 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After screening, participants will undergo a 2-week run-in period where they will wear a continuous glucose monitor and ketone sensor and receive education about management of sustained hyperglycemia/ketosis.
After run-in, participants will be randomized to either the intervention or placebo.
The intervention will be Sotagliflozin 200 mg oral tablet daily for three months.
Adherence to intervention will be monitored by counting number of study drugs returned at the end of intervention.
Wash-out period is 2 weeks between interventions.
Arm 1: Sotagliflozin for 12 weeks, then cross-over to Placebo for 12 weeks after washout
Arm 2: Placebo for 12 weeks, then cross-over to Sotagliflozin for 12 weeks after washout
Intervention code [1] 328122 0
Treatment: Drugs
Intervention code [2] 328123 0
Prevention
Comparator / control treatment
The control group will be a placebo control group. The placebo tablet will contain the same excipients without the active drug, comprising of croscarmellose sodium, colloidal silicondioxide, microcrystalline cellulose, magnesium stearate, and talc.
Control group
Placebo

Outcomes
Primary outcome [1] 337579 0
Percentage time in range (3.9-10.0 mmol/L) on continuous glucose monitor (measured over 2 weeks)
Timepoint [1] 337579 0
Daily during the final two weeks of each study arm (week 10 to 12 and week 24 to 26)
Primary outcome [2] 337580 0
Number of episodes of diabetic ketoacidosis
Timepoint [2] 337580 0
Daily throughout the study until week 26
Secondary outcome [1] 432367 0
Mean glucose on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [1] 432367 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [2] 432368 0
Glucose management indicator on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [2] 432368 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [3] 432369 0
Glycaemic variability on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [3] 432369 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [4] 432370 0
Percentage time above range (>13.9 mmol/L) on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [4] 432370 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [5] 432371 0
Percentage time above range (10.1-13.9 mmol/L) on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [5] 432371 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [6] 432372 0
Percentage time in range (3.9-10.0 mmol/L) on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [6] 432372 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [7] 432373 0
Percentage time below range (3.0-3.8 mmol/L) on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [7] 432373 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [8] 432376 0
Percentage time below range (<3.0 mmol/L) on continuous glucose monitor across entire day, daytime, nighttime and post-prandial
Timepoint [8] 432376 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [9] 432377 0
Glycaemic risk index
Timepoint [9] 432377 0
Final two weeks of each stage (week 10 to 12 and week 24 to 26) and for three months of each stage (week 0 to 12 and week 14 to 26) post-commencement of intervention
Secondary outcome [10] 432378 0
HbA1c
Timepoint [10] 432378 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [11] 432380 0
Percentage time ketone levels above 0.6 mmol/L
Timepoint [11] 432380 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [12] 432381 0
Percentage time ketone levels above 1.5 mmol/L
Timepoint [12] 432381 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [13] 432382 0
Percentage time ketone levels above 3.0 mmol/L
Timepoint [13] 432382 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [14] 432383 0
Number of episodes of severe hypoglycaemia
Timepoint [14] 432383 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [15] 432384 0
Mean ketone levels between midnight to 6am (likely fasting)
Timepoint [15] 432384 0
Final two weeks of each study arm (week 10 to 12 and week 24 to 26)
Secondary outcome [16] 432386 0
Mean ketone levels between 10am to 10pm (likely fed)
Timepoint [16] 432386 0
Final two weeks of each study arm (week 10 to 12 and week 24 to 26)
Secondary outcome [17] 432387 0
Change in weight
Timepoint [17] 432387 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [18] 432388 0
Change in body mass index
Timepoint [18] 432388 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [19] 432389 0
Change in estimated glomerular filtration rate
Timepoint [19] 432389 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [20] 432390 0
Change in albumin-creatinine ratio
Timepoint [20] 432390 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [21] 432391 0
Number of presentations with cardiac failure
Timepoint [21] 432391 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [22] 432392 0
Number of hospital presentations with cardiac ischaemia
Timepoint [22] 432392 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [23] 432393 0
Number of hospital admissions
Timepoint [23] 432393 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [24] 432394 0
Brain natriuretic peptide
Timepoint [24] 432394 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [25] 432395 0
Number of urinary tract infections
Timepoint [25] 432395 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [26] 432396 0
Number of candida infections
Timepoint [26] 432396 0
Daily throughout the study until week 26 (post commencement of intervention)
Secondary outcome [27] 432397 0
Average total daily insulin dose
Timepoint [27] 432397 0
Daily for two weeks at baseline (week -2 to 0), week 10 to 12 (post commencement of intervention) and week 24 to 26 (post commencement of intervention)
Secondary outcome [28] 432398 0
Average daily bolus insulin dose
Timepoint [28] 432398 0
Daily for two weeks at baseline (week -2 to 0), week 10 to 12 (post commencement of intervention) and week 24 to 26 (post commencement of intervention)
Secondary outcome [29] 432399 0
Average daily basal insulin dose
Timepoint [29] 432399 0
Daily for two weeks at baseline (week -2 to 0), week 10 to 12 (post commencement of intervention) and week 24 to 26 (post commencement of intervention)
Secondary outcome [30] 432400 0
Change in blood pressure
Timepoint [30] 432400 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [31] 432401 0
Change in lipids
Timepoint [31] 432401 0
Baseline (week 0/pre-intervention), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [32] 432402 0
Treatment satisfaction
Timepoint [32] 432402 0
Mid-study (week 12 post commencement of intervention) and end of study (week 26 post commencement of intervention)
Secondary outcome [33] 432403 0
Treatment satisfaction
Timepoint [33] 432403 0
Mid-study (week 12 post commencement of intervention) and end of study (week 26 post commencement of intervention)
Secondary outcome [34] 432404 0
Ketone sensor usability
Timepoint [34] 432404 0
Mid-study (week 12 post commencement of intervention) and end of study (week 26 post
commencement of intervention)
Secondary outcome [35] 432405 0
Psychosocial surveys
Timepoint [35] 432405 0
Baseline (week -2), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [36] 432406 0
Sleep
Timepoint [36] 432406 0
Baseline (week -2), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [37] 432407 0
Blood glucose psychological outcome
Timepoint [37] 432407 0
Baseline (week -2), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [38] 432408 0
Physical discomfort
Timepoint [38] 432408 0
Baseline (week -2), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)
Secondary outcome [39] 433190 0
Ketone sensor experience
Timepoint [39] 433190 0
Mid-study (week 12 post commencement of intervention) and end of study (week 26 post commencement of intervention)
Secondary outcome [40] 433191 0
Fatigue
Timepoint [40] 433191 0
Baseline (week -2), mid-study (week 12 post commencement of intervention), end of study (week 26 post commencement of intervention)

Eligibility
Key inclusion criteria
Age equal to or greater than 18 years; type 1 diabetes of more than 1 year duration; stable on insulin therapy; HbA1c <10.0%; access to a mobile phone compatible with the ketone monitoring system; willing to adhere to all requirements of the protocol including wearing and responding to information provided by the continuous ketone sensor for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or planned pregnancy; eGFR<30 ml/minute/1.73m2; a history of diabetic ketoacidosis in the last 3 months; diabetic gastroparesis; tape allergy; unable to exercise; use of low carbohydrate diet; heavy alcohol use; major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety

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)
Allocation will be concealed by bottles that are independently labelled at a central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
3/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,SA,VIC

Funding & Sponsors
Funding source category [1] 315988 0
Other Collaborative groups
Name [1] 315988 0
The Australian Centre for Accelerating Diabetes Innovations
Country [1] 315988 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318182 0
None
Name [1] 318182 0
Address [1] 318182 0
Country [1] 318182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314813 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314813 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314813 0
Australia
Date submitted for ethics approval [1] 314813 0
20/12/2023
Approval date [1] 314813 0
05/03/2024
Ethics approval number [1] 314813 0
302/23

Summary
Brief summary
This study aims to evaluate glucose control and safety with a sodium-glucose linked transporter in people living with type 1 diabetes. It will involve the use of continuous glucose monitoring and ketone sensing devices combined with education aimed at minimising the risk of diabetic ketoacidosis. The study will take place over seven months, comprising of two weeks of run-in, three months of intervention with sotagliflozin or placebo, followed by cross-over separated by a two week wash-out. Outcomes regarding glycaemia, ketones, anthropometric, cardio-renal, metabolic and psychological parameters will be assessed.
We hypothesize that glucose control will improve without a significant increase in diabetes ketoacidosis occurrences in people with type 1 diabetes on Sotagliflozin compared to placebo, with the use of continuous interstitial ketone monitoring in conjunction with education regarding management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132806 0
Prof David O'Neal
Address 132806 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Pde Fitzroy VIC 3065
Country 132806 0
Australia
Phone 132806 0
+61425731665
Fax 132806 0
Email 132806 0
dno@unimelb.edu.au
Contact person for public queries
Name 132807 0
Audrey Kong
Address 132807 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Pde Fitzroy VIC 3065
Country 132807 0
Australia
Phone 132807 0
+61433593020
Fax 132807 0
Email 132807 0
kongyw@unimelb.edu.au
Contact person for scientific queries
Name 132808 0
David O'Neal
Address 132808 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Pde Fitzroy VIC 3065
Country 132808 0
Australia
Phone 132808 0
+61425731665
Fax 132808 0
Email 132808 0
dno@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.