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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06820281




Registration number
NCT06820281
Ethics application status
Date submitted
6/02/2025
Date registered
11/02/2025

Titles & IDs
Public title
Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes
Scientific title
Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes: a Phase 2 Double Blinded Placebo Controlled Clinical Trial (TIRTLE2)
Secondary ID [1] 0 0
U1111-1316-2752
Universal Trial Number (UTN)
Trial acronym
TIRTLE2
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide 2.5mg weekly
Treatment: Drugs - Placebo injection (normal saline)

Experimental: Tirzepatide 2.5mg weekly - Administered subcutaneously.

Placebo comparator: Placebo - Administered subcutaneously.


Treatment: Drugs: Tirzepatide 2.5mg weekly
Tirzepatide 2.5 mg/0.5 mL solution for injection vial or pre-filled pen. Each vial/ pre-filled pen contains tirzepatide 2.5 mg in 0.5 mL solution (2.5mg in 0.6mL if Kwikpen)

Tirzepatide will be administered by drawing up into a syringe, then administering by subcutaneous injection weekly by study nurses.

Treatment: Drugs: Placebo injection (normal saline)
Placebo will be given as 0.5mL normal saline (if comparator against vial or pre-filled pen), or 0.6mL (if comparator against Mounjaro Kwikpen), drawn up into a syringe and administered by subcutaneous injection weekly by study nurses.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Whole-body insulin sensitivity
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Adipose insulin sensitivity
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Fasting glucagon
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Prandial glucagon secretion
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Glucagon response to hypoglycemia
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Resting energy expenditure (REE)
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Overnight growth hormone curve
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Overnight free-fatty acids (FFA) curve
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
% fat mass
Timepoint [8] 0 0
4 weeks
Secondary outcome [9] 0 0
% fat free mass
Timepoint [9] 0 0
4 weeks
Secondary outcome [10] 0 0
Body weight
Timepoint [10] 0 0
4 weeks
Secondary outcome [11] 0 0
Total daily insulin dose
Timepoint [11] 0 0
4 weeks
Secondary outcome [12] 0 0
Total daily basal insulin dose
Timepoint [12] 0 0
4 weeks
Secondary outcome [13] 0 0
Total daily bolus insulin dose
Timepoint [13] 0 0
4 weeks
Secondary outcome [14] 0 0
% Time in Range (TIR)
Timepoint [14] 0 0
4 weeks
Secondary outcome [15] 0 0
% Time Below Range (TBR)
Timepoint [15] 0 0
4 weeks
Secondary outcome [16] 0 0
% Time level 1 hyperglycemia
Timepoint [16] 0 0
4 weeks
Secondary outcome [17] 0 0
% Time level 2 hyperglycemia
Timepoint [17] 0 0
4 weeks
Secondary outcome [18] 0 0
Glycemic variability
Timepoint [18] 0 0
4 weeks
Secondary outcome [19] 0 0
Arterial stiffness
Timepoint [19] 0 0
4 weeks

Eligibility
Key inclusion criteria
* age 18-55 years
* BMI = 27 kg/m2
* HbA1c = 9.0%
* insulin delivery using an automated insulin delivery system
* at least 2 years since diagnosis of type 1 diabetes
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; steroids, antipsychotics, immunosuppressants in the last 6 weeks.
* Hypoglycemic unawareness or severe hypoglycemia last 6 months.
* History of seizure disorder.
* History of weight loss surgery.
* eGFR <60 mL/min/1.73 m2.
* Liver disease (known cirrhosis, LFTs > 3x upper limit of normal).
* Active malignancy.
* Pregnant, breastfeeding, planning pregnancy within 6 months, or not using adequate contraception.
* History of cardiovascular disease, or coronary event or stroke in last 3 months
* Hemoglobin level < 13.5 g/dL

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)
Methods used to generate the sequence in which subjects will be randomised (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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Garvan Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer R Snaith, MD PHD
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer R Snaith, MD PHD
Address 0 0
Country 0 0
Phone 0 0
+61 2 9298 8100
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06820281