Clinical trial NCT06180616: Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity
Official title: Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity: A Placebo-Matched Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Overweight and Obesity
Keywords: Tirzepatide
GLP-1/GIP Agonist
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control (measured by hbA1c), improve time in range, reduce insulin requirements, and reduce the severity of comorbidities in people with obesity and T1D. This trial includes a 6 month follow-up period.


Eligibility criteria: 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 ≥ 27kg/m2
* HbA1c ≤ 10%
* Capable and willing to self-inject tirzepatide once per week
* In women of childbearing potential, a negative pregnancy test and willing to use effective contraception consistently for the duration of the study
* 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

Exclusion Criteria:

* Age \<18 years and \>70 years
* A clinical diagnosis of diabetes type other than T1D
* HbA1c \> 10%
* Use of GLP-1 receptor agonist within 1 month 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 which is defined in Appendix 1
* 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
* No longer than 12 months of insulin treatment
* Not willing to use a NovoPen 6 to record insulin dosing if currently using multiple daily injections
* Insulin pump, CGM or smart phone devices are not compatible for data transfer
* Not willing to share device data
* Current use of any steroidal medication, or planned long-term steroidal treatment (\>4 weeks) during the study period
* Serum triglycerides \>500 mg/dL
* History of or plans for bariatric surgery during the study period
* eGFR \<45 ml/min/1.73 m2
* 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 heart failure
* 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)
* History of multiple endocrine neoplasia type 2, familial thyroid cancer, or non-familial medullary thyroid cancer
* 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 in other intervention trials during the study period
* Existence of any additional health conditions or medical issues, including significant psychiatric disorders, that render a person unfit for the study at the discretion of the investigators

Primary outcomes:
measure: Body weight
timeFrame: 32 weeks
Secondary outcomes:
measure: hbA1c
timeFrame: 32 weeks
measure: Time in range
timeFrame: 32 weeks
measure: Total daily insulin dose
timeFrame: 32 weeks
measure: Insulin carbohydrate ratio
timeFrame: 32 weeks
measure: Waist and neck circumference
timeFrame: 32 weeks
measure: Blood pressure
timeFrame: 32 weeks
measure: Mean glucose
timeFrame: 32 weeks
measure: Time in hypoglycaemia
timeFrame: 32 weeks
measure: Time in hyperglycaemia
timeFrame: 32 weeks
measure: Continuous glucose monitoring
timeFrame: 32 weeks
measure: Continuous glucose monitoring
timeFrame: 32 weeks
measure: Continuous glucose monitoring
timeFrame: 32 weeks
measure: Continuous glucose monitoring
timeFrame: 32 weeks
measure: Continuous glucose monitoring
timeFrame: 32 weeks
measure: Total cholesterol
timeFrame: 32 weeks
measure: Triglyceride
timeFrame: 32 weeks
measure: LDL-C
timeFrame: 32 weeks
measure: HDL-C
timeFrame: 32 weeks
measure: ACR
timeFrame: 32 weeks
measure: eGFR
timeFrame: 32 weeks
measure: HSI
timeFrame: 32 weeks
measure: FIB-4
timeFrame: 32 weeks
measure: Brachial-Ankle Pulse Wave Velocity using Ankle Brachial Index Machine
timeFrame: 32 weeks
measure: Arterial Stiffness using a Pulse Wave Tonometer
timeFrame: 32 weeks
measure: Aortic Stiffness using a Pulse Wave Tonometer
timeFrame: 32 weeks
measure: Left Ventricular Strain using Electrocardiogram
timeFrame: 32 weeks
Other outcomes:
Locations:
Study officials:
References: