Type 2 diabetes. Type 1 diabetes mellitus, Type 2 diabetes mellitus
Conditions
Interventions
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 base
Sponsors
Pooyesh darou
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Sina Ebrahimi
Pooyesh darou
Outcome results
None listed