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IRCT20150303021315N15 IRCT 2019-09-13 CinnaGen Company Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients with Type II Diabetes A randomized, two-armed, parallel, double-blind, active-controlled, non-inferiority clinical trial to compare efficacy and safety of test-liraglutide (CinnaGen Co., Iran) to innovator liraglutide product (Victoza®, Novo Nordisk, Denmark) in patients with type II diabetes (T2D) 2019-06-10 anticipated 300 Complete https://irct.ir/trial/28298 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization plan of the patients will be carried out centrally using an R-CRAN software version 3.2.3. Blocks (with the size 2 or 4) will be made using permuted block randomization for a total of 300 patients (1:1 allocation ratio). After randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the first two letters of first name, first two letters of surname) and 4 numbers (center code). Moreover, the described code is followed by study unique identification code consisting of first two letters of the generic name of the investigational product and study phase number, respectively (LI3), and four numbers (corresponding to the randomization number), e.g. ABCD0001LI3-0001. The randomization number will be assigned in a consecutive way, Blinding description: The medication compartment of both Victoza® and test-liraglutide (CinnaGen) will be placed in similar pen-injector containers, in a way that they cannot be differentiated by the appearance. Additionally, The center researcher and the patient are not aware of the drug grouping. 3 type 2 diabetes. Intervention 1: Liraglutide (produced by CinnaGen Co.) pen-injector (18 mg/3 ml), subcutaneous injection of 0.6 mg every day for one week, followed by a dose of 1.2 mg per day for up to three weeks. Then, 1.8 mg daily subcutaneous injection will be performed until the end of week 26. Intervention 2: Victoza® (produced by Novo Nordisk Company) pen-injector (18 mg/3 ml), subcutaneous injection of 0.6 mg every day for one week, followed by a dose of 1.2 mg per day for up to three weeks. Then, 1.8 mg daily subcutaneous injection will be performed until the end of week 26. 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 data for sharing.
public Nassim Anjidani
No. 42, Atar St, Attar Sq
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 anjidani.n@orchidpharmed.com Orchid Pharmed Co. scientific Mohammad Ebrahim Khamseh
Behafarin ST, Karimkhan AVE, Vali-asr Sq
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8894 5246 m.e.khamseh@gmail.com Institute of Endocrinology and Metabolism Research and Training Center 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) 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) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Subjects with type 2 diabetes treated for ≥ 3 months with a stable metformin dose of ≥1500 mg and at least half the maximum dose of a sulfonylurea or non-sulfonylurea insulin secretagogues agent(Half of maximum dose) 18–80years of age HbA1c equal or greater than 7 and equal or smaller than 10.5 Body mass index (BMI) of 20-45 kg/m2 18 years 80 years Both Lack of consent for being in the trial and not complying with 26-weeks follow-up period Hypersensitivity to liraglutide or any component of the formulation (excipients include Disodium phosphate dehydrate, Propylene glycol, Phenol, Water for injection) Insulin treatment during the previous 3 months (except short-term treatment for intercurrent illness) Impaired liver function (alanine aminotransferase concentrations equal to or greater than 2.5 times upper normal range). Impaired renal function (eGFR smaller than 60 mL/min/1.73 m2) Uncontrolled hypertension (equal or greater than 160/100 mmHg) Malignancy Using any drugs apart from OGLAs likely to affect glucose concentrations, including androgens, hyperglycemia-associated agents, hypoglycemia-associated agents, MAO inhibitors, quinolone antibiotics, salicylates (Anti-inflammatory dose). Current use of a dipeptidyl peptidase-4 inhibitor (DPP-4i) Treatment with systemic corticosteroids within last three months History or family history of Medullary Thyroid Carcinoma (MTC) Multiple endocrine neoplasia syndrome type 2 (MEN2) History of pancreatic cancer and pancreatitis History of recent MI, uncontrolled CHF, and unstable Angina within last 3 months History or known case of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy Pregnancy or breast-feeding Female who intends to become pregnant during the clinical trial period Previous exposure to exenatide or liraglutide. E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Liraglutide (produced by CinnaGen Co.) pen-injector (18 mg/3 ml), subcutaneous injection of 0.6 mg every day for one week, followed by a dose of 1.2 mg per day for up to three weeks. Then, 1.8 mg daily subcutaneous injection will be performed until the end of week 26. Victoza® (produced by Novo Nordisk Company) pen-injector (18 mg/3 ml), subcutaneous injection of 0.6 mg every day for one week, followed by a dose of 1.2 mg per day for up to three weeks. Then, 1.8 mg daily subcutaneous injection will be performed until the end of week 26. Change in HbA1c after 26 weeks of treatment. Timepoint: Screening, baseline, week 12, and week 26. Method of measurement: By High-performance liquid chromatography (HPLC). Percentages of subjects achieving HbA1c < 7.0%. Timepoint: Screening, baseline, week 12, and week 26. Method of measurement: -By High-performance liquid chromatography(HPLC). Percentages of subjects achieving HbA1c ≤ 6.5%. Timepoint: Screening, baseline week 12, and week 26. Method of measurement: By High-performance liquid chromatography(HPLC). Changes in body weight. Timepoint: Screening, baseline week 12, and week 26. Method of measurement: Scales. Changes in mean FBS. Timepoint: Baseline, week 12, and week 26. Method of measurement: Laboratory Test. Changes in mean PPBS. Timepoint: Baseline, week 12, and week 26. Method of measurement: Laboratory Test. Changes in Systolic Blood Pressure. Timepoint: Screening, baseline, week 4, week 8, week 12, and week 26. Method of measurement: Medical examination. Changes in Diastolic Blood Pressure. Timepoint: Screening, baseline, week 4, week 8, week 12, and week 26. Method of measurement: Medical examination. Changes in Lipid profiles. Timepoint: Baseline, week 12, and week 26. Method of measurement: Laboratory Test. Change in Pulse Rate. Timepoint: Screening, baseline, week 4, week 8, week 12, and week 26. Method of measurement: Medical examination. Change in eGFR. Timepoint: Screening, baseline, week 12, and week 26. Method of measurement: Laboratory Test. Change in ALT. Timepoint: Screening, Baseline, week 12, and week 26. Method of measurement: Laboratory Test. Change in liver AST. Timepoint: Baseline, week 12, and week 26. Method of measurement: Laboratory Test. Adverse events with special focus on the incidence, severity, and duration of gastrointestinal disturbances, nausea, vomiting, diarrhea; kidney function (BUN, SCr), liver function (ALT, AST, ALP), serum levels of Amylase and Lipase, tachycardia/palpitation, and antibody formation. Timepoint: Screening, baseline, week 4, week 8, week 12, week 16, week 20, and week 26. Method of measurement: evaluation adverse events and adverse drug reaction. Change in quality of life. Timepoint: Baseline, week 12 and week 26. Method of measurement: EQ5D questionnaire. Medication adherence. Timepoint: Baseline, week 12 and week 26. Method of measurement: Morisky questionnaire. Cost-effectiveness. Timepoint: Baseline, week 4, week 8, week 12, week 16, week 20 and week 26. Method of measurement: Cost-effectiveness questionnaire. Fear of injection. Timepoint: Baseline, week 12 and week 26. Method of measurement: D-FISQ questionnaire. NCT03421119 ClinicalTrial.gov CinnaGen Company Approved 2019-01-23 Ethics committee of Iran University of Medical Sciences Near Milad Tower, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of) Approved 2019-06-15 Ethics Committee of Alborz University of Medical Sciences Hassan Abad, Karaj, Alborz Province Karaj Alborz Iran (Islamic Republic of)