Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus oral hypoglycemic agents
Not Applicable
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000019354
- Lead Sponsor
- Shiraiwa Medical Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
- patients injecting bolus insulin and/or GLP-1 receptor agonist - patients expected to have other antidiabetic agents added, changed, or increased/decreased in dosage during the next 6 months - difficulty to perform self-monitoring blood glucose - Patients with severe hepatic, renal, and/or cardiac disease - Patients with hypersentitivity to the agents used in the current study - Patients who are pregnant, breast-feeding or may become pregnant - Patients who are judged by the investigator to be inappropriate for this study for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method glucose-lowering effect evaluated with HbA1c levels after three-month treatment
- Secondary Outcome Measures
Name Time Method - glucose-lowering effect evaluated with self-monitored blood glucose levels - subjective assessment of insulin injection - adverse events including hypoglycemia, weight gain, and other side effects