Type 2 Diabetes
Conditions
Interventions
Switch insulin glargin into innsulin glargin U-300 for 6 months
Switch insulin glargin into innsulin glargin biosimillar for 6 months
Sponsors
Nihon University Itabashi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criterias are shown as follows; 1.Patients aged 20 to 80 at the time of consent acquisition 2.Patient received insulin glargine for more than 1 year and performing self-blood glucose measurement as instructed by doctor. 3. Patients wiht HbA1c level ranged from 7.0% to less than 10.0%. 4.Patients who have the register's written consent of their's own free will after provided sifficient explanation and suffiency understood about this study.
Exclusion criteria
Exclusion criteria: The exclusion criterias are shown as follows; 1.Patients who are a possibility of pregnancy or pregnant. 2.Patients with severe ketosis, diabetic coma or pre coma. 3.Patents with severe infections, before and after surgery or serious traumatic injury. 4.Patients undergoing blood purification therapy. 5.Patients using implantable medical devices such as pacemakers. 6.Patients receiving steroid drugs. 7.Patients with dementia. 8.Patients who are judged as inappropriae for this study by reserchers . 9.Patients who refuse to be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In type 2 diabetes patients treated with insulin glargin, insulin glargin is switched into insulin glargin U-300 or insulin glargin biosimillar, and the difference of glucose metabolism between patients treating with insulin glargin U-300 and insulin glargin biosimillar are evaluated at 1, 2, and 3 months from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| In type 2 diabetes patients treated with insulin glargin, insulin glargin is switched into insulin glargin U-300 or insulin glargin biosimillar, and the difference of QOL, influence of hypoglycemia, lipid metabolism. blood pressure, and change of body weight between patients treating with insulin glargin U-300 and insulin glargin biosimillar are evaluated at 1,6 and 3 months from baseline. | — |
Countries
Japan
Contacts
Public ContactMidori Yamana
Nihon University Itabashi Hospital Division of Diabetes and Metabolic Diseases
Outcome results
None listed