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Study aim
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The objectives of this study are to assess effectiveness and safety of Spartina®
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Design
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Before-after, single-armed, prospective, real-world, non-randomized study in 38 patients
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Settings and conduct
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Eligible individuals presenting to the determined centers will enter the run-in period and will undergo CGM for one month. At the end of this period, they will be enrolled in the study if they meet all eligibility criteria upon final assessment.
Spartina® will be administered once weekly throughout the three-month study period. During the first month, the weekly dose will be 2.5 mg. If the medication is well tolerated, after one month the dose should be increased to 5 mg. In the third month, the dose may be increased to 7.5 mg at the physician's discretion.
Data will be collected throughout the treatment period and will undergo analysis and the results will be reported.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
1. Male or female between 18-60 years with at least 1-year history of type -1 diabetes and BMI ≥ 27
2. Willingness to consent
Exclusion criteria:
1. Use of any GLP-1 agonist or SGLT2 inhibitors or corticosteroids in the last 6 weeks
2. History of diabetic ketoacidosis, severe hypoglycemia, unstable coronary events or stroke in the last 3 months
3. History of bariatric surgery
4. Any condition that might pose a risk to the subject
5. Pregnancy or breast-feeding
6. History of proliferative diabetic retinopathy or macular edema.
7. Personal or family history of MTC or patients with MEN-2 syndrome
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Intervention groups
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Tirzepatide (2.5–7.5 mg once weekly), dose should be increased to 5 mg after the first month in case of good tolerability
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Main outcome variables
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WC, BMI, Weight, FBS, HbA1C, Glycemic variability, Insulin dose, Time of blood glucose in or out of range