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IRCT20201230049882N1 IRCT 2021-02-23 Pooyesh darou Assessment of efficacy of Basalin (Insulin glargine) in type 2 diabetes The assessment of the safety and efficacy of Basalin (Insulin glargine) in patients with type 2 diabetes: a postmarketing survey 2021-04-21 anticipated 400 Complete https://irct.ir/trial/53384 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 Type 2 diabetes. Intervention group: Insulin glargine Basalin, which is in 100 U / ml pens and is injected subcutaneously, will be prescribed to patients by an endocrinologist. The adjustment of drug dose will be based on the American Diabetes Association 2020 protocol.. 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 more information
public Dr. Sina Ebrahimi
NO. 13, 5th Ave, Fatemi St, Tehran, Iran
Tehran Iran (Islamic Republic of) 1415763863 +98 21 8899 4590 ebrahimi@pooyeshdarou.com Pooyesh darou scientific Mohammadreza Mohajeri-Tehrani
North karegar, shariati hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8822 0037 mrmohajeri@sina.tums.ac.ir endocrinology and metabolism research institute, Tehran university of medical sciences Iran (Islamic Republic of) Type 2 diabetic patients of both sexes and between 30-65 years of age. Patients who have been treated with oral glucose medications for at least 6 months prior to the start of the study and have not achieved their therapeutic goals (7.5%<HbA1C<9.5%) and not achieving the goals of glucose control with at least two oral antihyperglycemic agents with maximum tolerated dose Patients who have not received Lantus insulin glargine or any long-acting insulin in the last 6 months. Body mass index < 35 kg/m2 Glomerular filtration rate more than 30 ml/min. Following a caring diet and exercise regimen recommended by the medical team and tend to maintain them for the entire duration of the study. 30 years 65 years Both History of diabetic ketoacidosis before the study Hospital admission history more than 2 times due to diabetes in the last 1 year History of brittle diabetes (a condition in which the disease is very difficult to control, as the patient's blood sugar level fluctuates from very low to very high) The presence of any severe complications of diabetes, including end-stage renal disease, advanced coronary artery disease or myocardial infarction during the 6 months prior to the study, or autonomic peristaltic problems, such as gastroparesis. Laboratory disorders at the beginning of the study, such as high levels of liver enzymes more than 3 times above normal limit History of cirrhosis (CHILD C) Uncontrolled thyroid disease History of autoimmune diseases Treatment with glucocorticoids, immunosuppressive or cytotoxic drugs for 60 days prior to enrollment Presence of any active malignancy or history of malignancy History of drug or alcohol abuse (based on patient self-expression) Severe physical and mental disorders Pregnancy, breastfeeding or planning to get pregnant in the next 6 months Simultaneous participation of the patient in another clinical trial or taking any other study drug from 6 months before enrollment History of positive test results for HIV, hepatitis B or hepatitis C, or covid-19 History of organ transplantation E10, E11 Type 1 diabetes mellitus, Type 2 diabetes mellitus Treatment - Drugs Intervention group: Insulin glargine Basalin, which is in 100 U / ml pens and is injected subcutaneously, will be prescribed to patients by an endocrinologist. The adjustment of drug dose will be based on the American Diabetes Association 2020 protocol. HbA1c changes. Timepoint: At the beginning of the study, week 12 and week 24. Method of measurement: Chromatography. Blood glucose changes. Timepoint: At the beginning, week12 , and week 24. Method of measurement: Enzymatic method. Percentage of patients who achieve their blood sugar control goals. Timepoint: End of week 24 after starting the study. Method of measurement: Measuring Glycated hemoglobin using chromatography method. Pooyesh darou Approved 2021-01-11 Endocrine and metabolism research institute - Tehran university of medical sciences Next to Dr. Shariati Hospital, Jalal Al-Ahmad Highway Tehran Tehran Iran (Islamic Republic of)