Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes
About this study
This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.
- Condition
- Type 1 Diabetes Mellitus
- Tested
- Tirzepatide 2.5mg weekly, Placebo injection (normal saline)
- Sponsor
- Victor Chang Cardiac Research Institute
Who can join
- Age
- 18 to 70 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Maximum age: 70 years
- Study condition: Type 1 Diabetes Mellitus
- age 18-70 years
- BMI ≥ 25 kg/m2
- HbA1c ≤ 9.0%
- insulin delivery using an automated insulin delivery system
- at least 2 years since diagnosis of type 1 diabetes
Exclusion 11
- TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; systemic steroids, antipsychotics, 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.
- Coronary event or stroke in last 6 months
- Active or untreated proliferative diabetic retinopathy
- Hemoglobin level \< 13.5 g/dL in men, \< 12.0 g/dL in women
Where
1 site, 1 recruiting
Victor Chang Cardiac Research Institute
Sydney, New South Wales, Australia
Contact
-
Jennifer R Snaith, MD PHD
+61 2 9295 8600 j.snaith@victorchang.edu.au
-
Jerry R Greenfield, MD PHD
Potential match only. Final eligibility is determined by the study team.