| Outcome Measures: |
Primary: The primary endpoint of the study is the change from baseline of plasma C-peptide area under the curve (AUC) over 2 hours following a mixed meal., Measured at 48 weeks post commencement of intervention. | Secondary: Change from baseline in plasma C-peptide AUC over 2 hours following a mixed meal., Measured at weeks 12, 24, 72 and 96 post commencement of intervention.|Change from baseline in mean daily insulin use over 7 consecutive days., Measured during the 2 weeks prior to the assessment at weeks 12, 24, 48, 72 and 96 post commencement of intervention.|Change from baseline in glycosylated haemoglobin (HbA1c) levels., Measured at weeks 12, 24, 48, 72 and 96 post commencement of intervention.|Number of participants with responder status. Responder status is defined as glycosylated haemoglobin (HbA1c) less than or equal to 6.5 percent and mean daily insulin use less than 0.5 international units per kilogram per day (IU/kg/day)., Measured at weeks 12, 24, 48, 72 and 96 post commencement of intervention.|Change in estimated C-peptide (CPEST) from baseline. CPEST is calculated based on six variable routine measures: disease duration, BMI, insulin dose, HbA1c, fasting plasma C-peptide and fasting plasma glucose., Measured at weeks 12, 24, 48, 72 and 96 post commencement of intervention.|Continuous glucose monitoring (CGM)., Measured at baseline, 12, 24, 48 and 96 weeks post commencement of intervention.|The composite outcome assessing both the frequency, and when relevant, the severity of all adverse events., Adverse events will be monitored throughout the entire study duration at weeks 0, 2, 4, 8, 12, 16, 20, 24, 36, 48, 72 and 96.
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| Locations: |
Women's and Children's Hospital Adelaide, North Adelaide, South Australia, 5006, Australia|St Vincent's Hospital Melbourne, Fitzroy, Victoria, 3065, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Royal Children's Hospital Melbourne, Parkville, Victoria, 3052, Australia
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