Assessment of efficacy of Basalin (Insulin glargine) in type 2 diabetes

Phase 4

• Conditions: Type 2 diabetes.; Type 1 diabetes mellitus, Type 2 diabetes mellitus; E10, E11

• Registration Number: IRCT20201230049882N1
• Lead Sponsor: Pooyesh darou

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 400

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%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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	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.