The assessment of the safety and efficacy of Basalin (Insulin glargine) in patients with type 2 diabetes: a postmarketing survey

Pooyesh darou0 个研究点目标入组 400 人开始时间: 待定最近更新: 2021年4月26日

适应症

试验速览

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•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%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.

•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

发起方

Pooyesh darou