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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625000841471
Ethics application status
Approved
Date submitted
30/06/2025
Date registered
5/08/2025
Date last updated
5/08/2025
Date data sharing statement initially provided
5/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Tirzepatide for the treatment of concurrent type 1 diabetes and overweight or obesity 2.0 - an open-label randomised crossover trial in adults
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Scientific title
Tirzepatide for the treatment of concurrent type 1 diabetes and overweight or obesity 2.0 - an open-label randomised crossover trial in adults
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Secondary ID [1]
314768
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
TZP-T1D 2.0
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
337991
0
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Obesity
337992
0
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Overweight
337993
0
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Condition category
Condition code
Metabolic and Endocrine
334308
334308
0
0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomised 1:1 to receive tirzepatide alongside usual insulin treatment (Group A) vs. insulin treatment alone (Group B) for 28 weeks duration. After a 4 week wash out period the groups will be swapped so that Group B receives study drug and Group A does not for a further 28 weeks. This will be followed by a 3-month follow-up period.
Tirzepatide will be self-administered via standard KwikPen injection once weekly. The dose incrementation of study drug will occur every 4 weeks, for each individual participant, commencing at a 2.5mg dose that will be up-titrated at 2.5mg dose increments to a maximum of a 10mg dose, so long as there are no adverse effects (commonly gastrointestinal side effects are experienced by participants). If significant side effects are experienced, the dosage of tirzepatide can be reduced to the maximally tolerated dose (MTD). One further attempt can be made to increase the dosage, at the discretion of the participant and investigator. The MTD will be held for the duration of the study.
To monitor adherence to the intervention all used/unused KwikPen devices will be returned to the investigators at the next scheduled study visit (occurring monthly). Both dispensing and return records will be kept by the study investigators.
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Intervention code [1]
331370
0
Treatment: Drugs
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Comparator / control treatment
This crossover study design will use the "untreated" arm as control. The control group will receive standard of care which include insulin administration and dietary advice.
Dietary advice will consist of 8x 20-minute face-to-face consultations with a registered dietician specialising in diabetes and obesity management. These will occur consecutively for 4-months at the start of each treatment period (Week 0, 4, 8, & 12 & Week 32, 36, 40 & 44).
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Control group
Active
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Outcomes
Primary outcome [1]
341972
0
Change in body weight (%)
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Assessment method [1]
341972
0
Weight measured in kilograms using standard scales and weight rounded out to nearest 0.1kg. As weight change is the primary endpoint in this study, patients will be provided with a standard hospital gown and given privacy to remove all other clothing and shoes prior to obtaining this measurement. Data will be reported as absolute change in body weight as well as proportion of participants reaching up to 5%, 10, 15% and 20% body weight loss.
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Timepoint [1]
341972
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End of each treatment period (Visit 10 -week 28 post-baseline vs Baseline -week 0 & visit 19-week 60 vs visit 11-week 32 post-baseline)
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Secondary outcome [1]
449186
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Change in CGM metrics, time-in-range
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Assessment method [1]
449186
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Measured using a standardised Libre continuous glucose monitoring device and extracted from reports spanning a 2-week period. Target range will be set to a standard range of 3.9-10mmol/L.
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Timepoint [1]
449186
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [2]
449187
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Change in insulin requirements
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Assessment method [2]
449187
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Data will be downloaded from patient automated insulin devices or self-reported multiple daily dose records.
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Timepoint [2]
449187
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [3]
449190
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Change in Body mass index (BMI)
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Assessment method [3]
449190
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Body mass index (BMI) will be calculated based on patient height and weight as kg/m2. These will be measured using a stadiometer and digital scales respectively.
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Timepoint [3]
449190
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baseline, at each dose incrementation (visit 4, 5, 6, 7 & visit 13, 14, 15, 16), visit 10 (week 28 post-baseline), visit 19 (week 60 post-baseline), follow up (Week 64 & 72 post-baseline).
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Secondary outcome [4]
449191
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Change in Heart morphology
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Assessment method [4]
449191
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Changes in heart morphology will be mapped using a transthoracic echocardiogram.
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Timepoint [4]
449191
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [5]
449192
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Changes in bone density
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Assessment method [5]
449192
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Dual-energy X-ray absorptiometry bone density scan (DXA) will be used to evaluate overall bone density.
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Timepoint [5]
449192
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [6]
449193
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Urine marker, albumin:creatinine ratio
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Assessment method [6]
449193
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This will be measured using routine laboratory measures completed by local pathology.
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Timepoint [6]
449193
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [7]
449194
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Identification of novel biomarkers related to TZP use in un-fasted blood samples (exploratory outcome)
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Assessment method [7]
449194
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Blood samples will be utilised for discovery based multi-omics analysis.
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Timepoint [7]
449194
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visit 2 (week 0), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12), visit 7 (week 16), visit 11 (week 32), visit 13 (week 36), visit 14 (week 40), visit 15 (week 44), and visit 16 (week 48) post-baseline.
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Secondary outcome [8]
449195
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Satisfaction with diabetes treatment
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Assessment method [8]
449195
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The DTSQ questionnaire: Diabetes Treatment Satisfaction Questionnaire, will be completed.
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Timepoint [8]
449195
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [9]
449236
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Ankle brachial index
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Assessment method [9]
449236
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ABI is calculated by a digital pulse wave diagnosis machine that simultaneously measures right and left side systolic and diastolic pressure using bicep and calf cuffs.
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Timepoint [9]
449236
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [10]
449237
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Changes in liver mass
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Assessment method [10]
449237
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The liver will be imaged using MRI. Liver size will be quantified digitally.
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Timepoint [10]
449237
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Baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [11]
449916
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Change in HbA1C
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Assessment method [11]
449916
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HbA1C will be measured in blood from fasted patients by local pathology.
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Timepoint [11]
449916
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Screening (2 weeks pre baseline), Visit 10 (week 28) and Visit 19 (week 60).
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Secondary outcome [12]
449917
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Change in CGM metrics, Time-below-range
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Assessment method [12]
449917
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Measured using a standardised Libre continuous glucose monitoring device and extracted from reports spanning a 2-week period. Below range will be set to a standard 3.9 mmol/L
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Timepoint [12]
449917
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [13]
449918
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Change in CGM metrics, Time-above-range
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Assessment method [13]
449918
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Measured using a standardised Libre continuous glucose monitoring device and extracted from reports spanning a 2-week period. Above range will be set to a standard 10 mmol/L.
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Timepoint [13]
449918
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [14]
449919
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Change in waist circumference
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Assessment method [14]
449919
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waist circumference will be measured with a standard measuring tape in cm.
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Timepoint [14]
449919
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baseline, at each dose incrementation (visit 4, 5, 6, 7 & visit 13, 14, 15, 16), visit 10 (week 28 post-baseline), visit 19 (week 60 post-baseline), follow up (Week 64 & 72 post-baseline).
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Secondary outcome [15]
449920
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Change in neck circumference
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Assessment method [15]
449920
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neck circumference will be measured with a standard measuring tape in cm.
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Timepoint [15]
449920
0
baseline, at each dose incrementation (visit 4, 5, 6, 7 & visit 13, 14, 15, 16), visit 10 (week 28 post-baseline), visit 19 (week 60 post-baseline), follow up (Week 64 & 72 post-baseline).
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Secondary outcome [16]
449921
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Change in Electrocardiogram (ECG) pattern
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Assessment method [16]
449921
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A 12- lead electrocardiogram (ECG) will be performed and run through an algorithm to identify changes in the patterns observed in the ECG.
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Timepoint [16]
449921
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [17]
449922
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Change in blood pressure, systolic
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Assessment method [17]
449922
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Blood pressure measurements will be taken using a locally available digital blood pressure monitor, Systolic pressure will be recorded from this device to the nearest mmHg.
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Timepoint [17]
449922
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [18]
449923
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Change in blood pressure, diastolic,
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Assessment method [18]
449923
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Blood pressure measurements will be taken using a locally available digital blood pressure monitor, Diastolic pressure will be recorded from this device to the nearest mmHg.
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Timepoint [18]
449923
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [19]
449924
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Change in mean arterial blood pressure
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Assessment method [19]
449924
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Blood pressure measurements will be taken using a locally available digital blood pressure monitor. Mean arterial pressure (MAP) will be calculated from both systolic (SBP) and diastolic (DBP) pressure using the formula MAP=DBP + 1/3(SBP-DBP).
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Timepoint [19]
449924
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [20]
449925
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Change in heart rate
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Assessment method [20]
449925
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Heart rate measurements will be taken using a locally available digital blood pressure monitor.
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Timepoint [20]
449925
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [21]
449926
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Changes in body fat %
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Assessment method [21]
449926
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Dual-energy X-ray absorptiometry bone density scan (DXA) will be used to evaluate overall body fat %.
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Timepoint [21]
449926
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [22]
449927
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Changes in lean mass %
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Assessment method [22]
449927
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Dual-energy X-ray absorptiometry bone density scan (DXA) will be used to evaluate overall lean mass %.
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Timepoint [22]
449927
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [23]
449928
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Changes in muscle mass
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Assessment method [23]
449928
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Magnetic Resonance Imaging of the lower lumbar, pelvic and upper quad regions will be used to evaluate muscle mass.
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Timepoint [23]
449928
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [24]
449929
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Changes in % muscle fat infiltration
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Assessment method [24]
449929
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Magnetic Resonance Imaging of the lower lumbar, pelvic and upper quad regions will be used to evaluate %muscle fat infiltration.
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Timepoint [24]
449929
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [25]
449933
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Identification of novel biomarkers associated with TZP use in urine samples (exploratory outcome)
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Assessment method [25]
449933
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Urine samples will be utilised for discovery based multi-omics analysis.
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Timepoint [25]
449933
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visit 2 (week 0), visit 4 (week 4), visit 5 (week 8), visit 6 (week 12), visit 7 (week 16), visit 11 (week 32), visit 13 (week 36), visit 14 (week 40), visit 15 (week 44), and visit 16 (week 48) post-baseline.
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Secondary outcome [26]
449934
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Diabetes-associated distress
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Assessment method [26]
449934
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The T1-DDAS questionnaire: The Type 1 Diabetes Distress Assessment System, will be completed
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Timepoint [26]
449934
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [27]
449935
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Impact of weight on quality of life
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Assessment method [27]
449935
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The IWQOL-Lite-CT: Impact of Weight on Quality of Life-Lite Clinical Trials Questionnaire will be completed.
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Timepoint [27]
449935
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [28]
449936
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Cardiovascular disease risk
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Assessment method [28]
449936
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Brachial-ankle pulse wave velocity (baPWV) will be measured using a clinically available pulse wave diagnostic device and cardiovascular disease risk will be determined as high, moderate or low using a standard age corrected range.
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Timepoint [28]
449936
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [29]
449939
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Arterial stiffness
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Assessment method [29]
449939
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Arterial stiffness will be measured using arterial tonometry. This test is non-invasive and uses arterial pressure waveform by applanating a superficial artery with an external transducer.
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Timepoint [29]
449939
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [30]
449940
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Change in % liver fat infiltration (optional for the participant)
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Assessment method [30]
449940
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The liver will be imaged using MRI to look at %liver fat infiltrate. This will be quantified digitally.
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Timepoint [30]
449940
0
baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [31]
449941
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Routine blood marker, total cholesterol
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Assessment method [31]
449941
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Routine laboratory measures will be conducted by local pathology.
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Timepoint [31]
449941
0
screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [32]
449942
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Routine blood marker, LDL (Low-Density Lipoprotein)
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Assessment method [32]
449942
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Routine laboratory measures will be conducted by local pathology.
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Timepoint [32]
449942
0
screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [33]
449943
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Routine blood marker, HDL (High-Density Lipoprotein)
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Assessment method [33]
449943
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Routine laboratory measures will be conducted by local pathology.
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Timepoint [33]
449943
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screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [34]
450028
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Routine blood test, EUC (Electrolytes Urea & Creatinine)
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Assessment method [34]
450028
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Routine laboratory measures will be conducted by local pathology.
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Timepoint [34]
450028
0
screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [35]
450029
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Routine blood test, TSH (Thyroid Stimulating Hormone)
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Assessment method [35]
450029
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Routine laboratory measures will be conducted by local pathology.
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Timepoint [35]
450029
0
screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [36]
450030
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Routine blood test, triglycerides
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Assessment method [36]
450030
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Routine laboratory measures will be conducted by local pathology.
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Timepoint [36]
450030
0
screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [37]
450031
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Routine blood test, FBC (Full blood count), B12, folate, iron, and vitamin D (Outcomes will be assessed separately)
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Assessment method [37]
450031
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These 5 separate routine laboratory measures will be conducted by local pathology on blood samples. Each parameter described will be evaluated separately using standard tests available through local pathology.
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Timepoint [37]
450031
0
screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [38]
450034
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Changes in nutritional intake - carbohydrate intake, protein intake, fibre intake, sodium intake (Outcomes will be assessed separately)
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Assessment method [38]
450034
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Measured using the validated food frequency questionnaire.
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Timepoint [38]
450034
0
screening (2 weeks pre baseline), visit 10 (week 28), visit 19 (week 60) post-baseline.
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Secondary outcome [39]
450273
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Changes in muscle function - force, endurance, mobility and fitness (Outcomes will be assessed separately)
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Assessment method [39]
450273
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Each will be assessed using a validated and standardized exercise physiology test: Force - maximum quad force will be measured using a dynamometer endurance - a wall sit test to failure will be completed mobility - a 30-second sit stand test will be completed fitness - a 6-minute walk test tracking heartrate and SpO2 will be done.
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Timepoint [39]
450273
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baseline, visit 10 (week 28), visit 19 (week 60) post-baseline.
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Eligibility
Key inclusion criteria
• Age 18-70 years at screening
• A clinical diagnosis of T1D for at least 12 months at time of screening
• Body mass index greater than or equal to 27kg/m2
• HbA1c less than or equal to 10%
• Capable and willing to self-inject tirzepatide once per week
• In women of childbearing potential, a negative pregnancy test is required prior to commencing the study drug and every visit whilst receiving the study drug
• All participants must be willing to use effective contraception consistently for the duration of the study. Female participants of childbearing potential must agree to use highly effective measures of contraception consistently and correctly which will be documented by the study investigators.
• Able and willing to provide written informed consent for study participation
• Able and willing to use Easy Diet Diary
• Able and willing to keep an exercise log
• Willing to share devices data uploads
• Has current glucagon product to treat severe hypoglycaemia
• Has current ketone meters to check ketones
• Willingness to abstain from off-study glucagon-like peptide-1 (GLP1) use during their untreated phase
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Minimum age
18
Years
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Maximum age
70
Years
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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
• Age < 18 years and > 70 years
• A clinical diagnosis of diabetes type other than T1D
• HbA1c > 10%
• Use of glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months of study screening
• Use of any glucose lowering medications aside from insulin within 1 month of study screening
• History of hypersensitivity to investigational medicinal product or related product
• Obesity that is induced by other endocrine disorders
• Pregnancy or positive pregnancy test at time of screening, or unwilling to use effective contraception consistently for the duration of the study.
• Active proliferative diabetic retinopathy, maculopathy, or severe no proliferative diabetic retinopathy requiring acute treatment
• Known gastric emptying abnormality
• History of chronic or acute pancreatitis, uncontrolled hypertension, acute cardiovascular condition within 3 months
• Less than 12 months of insulin treatment
• Not willing to use a NovoPen 6 to record insulin dosing if currently using multiple daily injections
• Non compatible devices (e.g. pump, continuous glucose monitor (CGM) or smart phones) for data transfer
• Not willing to share device data
• Current use of any steroidal medication, or anticipated long-term steroidal treatment during the study period
• Serum triglycerides >500 mg/dL
• Planning for bariatric surgery during the study period
• eGFR <45 ml/min/1.73 m^2
• History of severe hypoglycaemia (within 3 months of trial period)
• History of diabetic ketoacidosis (within 3 months of trial period)
• History of stroke (within 3 months of trial period)
• History of congestive heart failure class III or IV
• Planned coronary, carotid, or peripheral artery revascularisation
• History of acute or chronic liver disease
• History of allergy to any form of insulin, GLP-1RA or its excipients
• History of malignancy requiring chemotherapy, surgery, or radiation (within 5 years of trial period)
• Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma
• Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening
• Have a pacemaker, or metal implants
• Participation to other intervention trials during the study period
• Presence of any comorbidities or medical conditions, such as severe psychiatric disorders, that render a person unfit for the study at the discretion of the investigators.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was at central administration site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The participant numbers (nT = 60, 30/study arm) were powered based on weight reduction observed in the retrospective cohort study by S. K. Garg et al. The sample size formula used for this study compared two independent means with unequal variances to calculate the number of required study participants based on a significance level of 0.05 and a desired power of 80%. This was then increased to account for a 15% drop out rate.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/08/2025
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Actual
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Date of last participant enrolment
Anticipated
14/08/2026
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Actual
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Date of last data collection
Anticipated
14/01/2028
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
28155
0
Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
44364
0
2065 - St Leonards
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Funding & Sponsors
Funding source category [1]
319319
0
Hospital
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Name [1]
319319
0
Royal North Shore Research Grants Scheme
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Address [1]
319319
0
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Country [1]
319319
0
Australia
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Funding source category [2]
319333
0
Hospital
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Name [2]
319333
0
Department of Diabetes, Metabolism & Endocrinology, Royal North Shore Hospital
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Address [2]
319333
0
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Country [2]
319333
0
Australia
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Primary sponsor type
Hospital
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Name
Department of Diabetes, Metabolism & Endocrinology, Royal North Shore Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
321797
0
None
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Name [1]
321797
0
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Address [1]
321797
0
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Country [1]
321797
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317899
0
Northern Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
317899
0
https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
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Ethics committee country [1]
317899
0
Australia
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Date submitted for ethics approval [1]
317899
0
28/10/2024
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Approval date [1]
317899
0
29/07/2025
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Ethics approval number [1]
317899
0
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Summary
Brief summary
The prevalence of obesity in patients with T1D is increasing. The common consequences of obesity in individuals with T1D include, insulin resistance, increased insulin requirements and impaired glycaemic control, increasing the risk of diabetes-related complications in these individuals. Novel therapeutic strategies that reduce body weight and synergistically aid insulin therapy in improving glycaemic control are therefore needed to address this challenge and reduce their risk of life-threatening diabetic complications. Tirzepatide is an incretin-based therapy commonly used in patients with type 2 diabetes and/or obesity that has proven effective for reducing body weight and improving glycaemic control. Therefore, this study aims to evaluate the efficacy of tirzepatide in individuals with concurrent T1D and overweight or obesity who are receiving insulin therapy in a cross-over randomised study design. The aim is to evaluate if adjunctive insulin therapy with tirzepatide can lead to a reduction in body weight and improved metabolic outcomes compared to insulin treatment alone.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
142506
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A/Prof Sarah J Glastras
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Address
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Department of Diabetes, Metabolism & Endocrinology, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
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Australia
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Phone
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+61 0425255625
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Email
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[email protected]
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Contact person for public queries
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Matilda Longfield
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Address
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Department of Diabetes, Metabolism & Endocrinology, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
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Australia
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Phone
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+61 0447123258
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Email
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[email protected]
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Contact person for scientific queries
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Sarah J Glastras
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Department of Diabetes, Metabolism & Endocrinology, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
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Australia
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Phone
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+61 0425255625
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
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Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
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De-identified individual participant data:
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Published results
What types of analyses could be done with individual participant data?
•
Systematic reviews and meta-analyses
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Studies exploring new research questions
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Studies testing whether findings can be repeated or confirmed
•
Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
A.Prof Sarah Glastras
[email protected]
Are there extra considerations when requesting access to individual participant data?
Yes:
Some specific data may not be available for sharing due to data storage policies determined by the NSLHD HREC committee.
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.
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