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IRCT20101012004920N12 IRCT 2024-09-03 Artiman Pharmed Alborz Company Phase III Clinical Trial, Efficacy and Safety of Dulagtima in Comparison with Trulicity® Phase III, Randomized, Parallel Groups, Open-label, Active-control, Non-inferiority Clinical Trial on Efficacy and Safety of Dulagtima (Dulaglutide by Artiman Pharmed Alborz) in Comparison with Trulicity® (Dulaglutide by Eli Lilly) in the Treatment of Type 2 Diabetic Patients 2024-10-22 anticipated 200 Complete https://irct.ir/trial/78552 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the recruitment process at each site, a numerical sequence for randomizing patients between two treatment groups is created using successive and random permuted blocks, with a block size of 6. The randomization is done in a 1:2 ratio, so each block of 6, randomly includes 4 codes for Dulaglutima and 2 for Trulicity. The generated random sequence is placed at the study sites. Each randomization code corresponds to a drug package (one of the two intervention groups), which is labeled and stored in the drug stock at the study site. After confirming the patient’s eligibility and obtaining informed consent, the corresponding drug, based on the order specified in the randomization table, is injected into the patient. 3 Type 2 diabetes. Intervention 1: Intervention group: (Dulaglutide manufactured by Artiman Pharmed Alborz Company) for 18 weeks, as a subcutaneous injection first with a dose of 0.75 mg for 4 weeks and then a dose of 1.5 mg for the next 14 weeks. Intervention 2: Control group: Trulicity (Dulaglutide manufactured by Eli Lilly) for 18 weeks, as a subcutaneous injection first with a dose of 0.75 mg for 4 weeks and then a dose of 1.5 mg for the next 14 weeks. 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 Ramin Heshmat
No 10, Jalale Al Ahmad St.
Tehran Iran (Islamic Republic of) 1411713119 +98 21 8822 0086 rheshmat@tums.ac.ir Tehran University of Medical Sciences scientific Alireza Esteghamati
Ibn Sina Medical Building, Motahari St., before Shariati Ave.
Tehran Iran (Islamic Republic of) 1567718570 +98 21 8841 7918 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) Patients diagnosed with type 2 diabetes for at least 3 months Age between 25 and 70 years when entering the study, applicable to both sexes. Consent to participate in the study and sign a written informed consent form 7.5 % ≤ HbA1c ≤ 10% BMI more than 25 and equal or less than 40 25 years 70 years Both Patients who intend to participate in another clinical trial during the study. Patients with type 1 diabetes Patients who have used other GLP-1 or DPP4 receptor agonist drugs within 3 months before the study. Patients who are currently using bolus insulin for diabetes treatment (basal insulin use is allowed). Patients who have had a change in dose or type of diabetes medication in the 3 months prior to entering the study Patients who have had one or more hospitalizations in the past 6 months due to lack of diabetes control. Abnormalities in gastric emptying, such as severe diabetic gastroparesis or gastric outlet obstruction, and plans for bypass or obesity-related surgeries during the study. Have a history of a heart or brain problem such as heart attack, chest pain (except heartburn), angioplasty or stenting, or stroke within 6 months before screening. Patients with severe renal failure (GFR <30 mL/minute/1.73 m2) Patients with liver cirrhosis or alanine transaminase (ALT) levels greater than 3 times the upper limit of normal. Patients with active malignancy or patients who are recovering from cancer in less than 5 years. Patients with a history of organ transplantation. Patients with a blood disorder that affects blood sugar measurements or laboratory samples Pregnant or lactating women or women who intend to become pregnant during the study period History of chronic or acute pancreatitis. Personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 Diagnosis of proliferative retinopathy or maculopathy E11.9 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: (Dulaglutide manufactured by Artiman Pharmed Alborz Company) for 18 weeks, as a subcutaneous injection first with a dose of 0.75 mg for 4 weeks and then a dose of 1.5 mg for the next 14 weeks Control group: Trulicity (Dulaglutide manufactured by Eli Lilly) for 18 weeks, as a subcutaneous injection first with a dose of 0.75 mg for 4 weeks and then a dose of 1.5 mg for the next 14 weeks Glycosylated hemoglobin (HbA1C) change at week 18 compared to baseline. Timepoint: At the beginning and week 18. Method of measurement: Measuring by the central laboratory. Glycemic control (change in fasting blood sugar) at week 18 compared to the baseline. Timepoint: At the baseline and week 18. Method of measurement: Measuring of fasting blood sugar by the central laboratory. Weight changes in the 18th week compared to the baseline state. Timepoint: At the baseline and week 18. Method of measurement: Using digital weight scale. The proportion of patients who achieve an HbA1c of less than 7. Timepoint: Week 18. Method of measurement: Dichotomized HbA1c level at the cut-off of 7. Frequency of side effects or serious side effects during 18 weeks. Timepoint: 7 days after the screening visit, 1+7 days after the 1st visit, 3+28 days after the 1st visit, 3+42 days after the 1st visit, 3+56 days after the 1st visit, 3+70 days after the visit 1, 84+3 days after visit 1, 98+3 days after visit 1, 112+3 days after visit 1, 126+3 days after visit 1. Method of measurement: Self-reporting by the individual during in-person and phone visits. Frequency of patients with anti-drug antibodies. Timepoint: Week 18. Method of measurement: Elisa test on patients' sera. Artiman Pharmed Alborz Company Approved 2024-08-28 Ethical Committee for Research of Medical School - Tehran University of Medical Sciences Northern Entrance of Tehran University - PourSina St. - Keshavarz Blv. Tehran Tehran Iran (Islamic Republic of)