]>
IRCT20150303021315N47 IRCT 2026-10-29 CinnaGen Company Before-after study of Spartina® (CinnaGen Co.) Evaluating the effectiveness and safety of Spartina® (Tirzepatide manufactured by CinnaGen Co.) in patients with obesity and type 1 diabetes 2026-10-31 anticipated 38 Recruiting https://irct.ir/trial/93267 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 Diabetes type 1 and obesity. Following the completion of the one-month run-in period, the patient's eligibility for study participation will be reassessed, including a review of continuous blood glucose monitoring results. Treatment with Spartina® (Tirzepatide manufactured by CinnaGen Co.) will then be initiated at a dose of 2.5 mg using an autoinjector or pen injector. The medication will be administered subcutaneously once weekly in the periumbilical area, upper arm, or thigh. If the medication is well tolerated, the dose will be increased to 5 mg once weekly in the second month, at the discretion of the treating physician and in accordance with routine clinical practice. If clinically indicated based on the patient's condition, the dose may also be increased to 7.5 mg once weekly in the third month. The total treatment duration will be three months.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Hamidreza Kafi
No 42. Attar sq, Attar st, Valiasr st, Vanak sq, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 Kafi.H@orchidpharmed.com Zist Orchid Pharmed Co scientific Dr. Alireza Esteghamati
Unit 4, Ibn Sina Building, End of Motahari Street, Just Before Shariati Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1567617117 +98 21 2239 5398 esteghamati@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Male or female between 18-60 years of age (inclusive) with at least 1-year history of type -1 diabetes BMI ≥ 27 Ability to comprehend and willingness to give consent for this study 18 years 60 years Both Prior use of any GLP-1 agonist or SGLT2 inhibitors or corticosteroids in the last 6 weeks History of diabetic ketoacidosis, severe hypoglycemia, unstable coronary events or stroke in the last 3 months History of previous weight loss surgery Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data Pregnancy or breast-feeding History of proliferative diabetic retinopathy or macular edema Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) E10, E66.9 Type 1 diabetes mellitus, Obesity Treatment - Drugs Following the completion of the one-month run-in period, the patient's eligibility for study participation will be reassessed, including a review of continuous blood glucose monitoring results. Treatment with Spartina® (Tirzepatide manufactured by CinnaGen Co.) will then be initiated at a dose of 2.5 mg using an autoinjector or pen injector. The medication will be administered subcutaneously once weekly in the periumbilical area, upper arm, or thigh. If the medication is well tolerated, the dose will be increased to 5 mg once weekly in the second month, at the discretion of the treating physician and in accordance with routine clinical practice. If clinically indicated based on the patient's condition, the dose may also be increased to 7.5 mg once weekly in the third month. The total treatment duration will be three months. Change in body weight from baseline after 12 weeks. Timepoint: Day 0, Week 12. Method of measurement: Weighting with scale. Proportion of patients with equal to or more than 5% weight loss at week 12. Timepoint: Day 0, Week 12. Method of measurement: Weighting with scale. Percent change in body weight from baseline till week 12. Timepoint: Day 0, Week 12. Method of measurement: Weighting with scale. Change from baseline in waist circumference (WC) at week 12. Timepoint: Day 0, Week 12. Method of measurement: Measurement by tape. Change from baseline in fasting blood sugar (FBS) at week 12. Timepoint: Day 0, Week 12. Method of measurement: Laboratory test. Change from baseline in HbA1C at week 12. Timepoint: Day 0, Week 12. Method of measurement: Laboratory test. Change from baseline in total daily Insulin dose at week 12. Timepoint: Day 0, Week 12. Method of measurement: Insulin dose. Change from baseline in total basal and bolus insulin dose (including rapid acting insulin types) at week 12. Timepoint: Day 0, Week 12. Method of measurement: Insulin dose. Percent change from baseline in total daily Insulin dose at week 12. Timepoint: Day 0, Week 12. Method of measurement: Insulin dose. Change from baseline to week 12 in glycemic variability assessed by continuous glucose monitoring (CGM). Timepoint: Day 0, Week 12. Method of measurement: CGM. Change from baseline to week 12 in percentage of time of blood glucose assessed by CGM in range (70-180 mg/dL). Timepoint: Day 0, Week 12. Method of measurement: CGM. Change from baseline to week 12 in percentage of time of blood glucose assessed by CGM >180 mg/dL. Timepoint: Day 0, Week 12. Method of measurement: CGM. Change from baseline to week 12 in percentage of time of blood glucose assessed by CGM <70 mg/dL. Timepoint: Day 0, Week 12. Method of measurement: CGM. CinnaGen Company Approved 2026-09-08 Ethics committee of Tehran University of Medical Sciences Central Building, Tehran University of Medical Sciences, Keshavarz Boulevard, at the intersection of Qods Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)