Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity

Официальное название

Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity: A Placebo-Matched Randomised Controlled Trial

Обзор

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.

Вмешательства

• Препарат Tirzepatide
  Tirzepatide will be self-administered subcutaneously by study participants via an injection. The drug will be taken weekly following the schedule: 4 weeks at 2.5 mg QW, 4 weeks at 5.0 mg QW, 4 weeks at 7.5 mg QW, 4 weeks at 10.0 mg QW, 4 weeks at 12.5 mg QW, 12 weeks at 15 mg QW. Modification of study drug will be performed if the participant is experiencing significant side effects and cannot tolerate the higher dosage of the study drug. In this instance, the study drug dosage will be reduced

Первичные конечные точки

• Body weight [Срок оценки: 32 weeks]

Вторичные конечные точки (12)

• hbA1c [Срок оценки: 32 weeks]
• Time in range [Срок оценки: 32 weeks]
• Total daily insulin dose [Срок оценки: 32 weeks]
• Insulin carbohydrate ratio [Срок оценки: 32 weeks]
• Waist and neck circumference [Срок оценки: 32 weeks]
• Blood pressure [Срок оценки: 32 weeks]
• Mean glucose [Срок оценки: 32 weeks]
• Time in hypoglycaemia [Срок оценки: 32 weeks]
• Time in hyperglycaemia [Срок оценки: 32 weeks]
• Continuous glucose monitoring [Срок оценки: 32 weeks]
• Continuous glucose monitoring [Срок оценки: 32 weeks]
• Continuous glucose monitoring [Срок оценки: 32 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Purcell AR, Rodrigo N, Longfield MSG, Glastras SJ. Tirzepatide for the treatment of adults living with concurrent type 1 diabetes and overweight or obesity (TZP-T1D): a double-blind, placebo-matched randomised controlled trial protocol. BMJ Open. 2025 Sep 16;15(9):e093775. doi: 10.1136/bmjopen-2024-093775. PMID 40962353

Идентификаторы

NCT: NCT06180616 · TZP-T1D

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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