Type 1 diabetes mellitus and type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) The patient who had a diagnosis of type 1 and 2 diabetes. 2) The patient who is more than HbA1C 7 % and receiving treatment with sustained-release dissolution insulin by once a day more than three months. 3) Male and Female,the age 20 years old or older.
Exclusion criteria
Exclusion criteria: 1) The patients are pregnant or have possibility of pregnancy. 2) The patients with hypersensitivity for Insulin Glargin U-300. 3) The patients with serious complications and considered inappropriate to participate in this study by the doctor in charge. 4) The patients whose HbA1c fluctuated more than 1.0% within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| usability and satisfaction of the change to insulin glargine U-300 by using Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in bodyweight,insulin dose,glucose (fasting),HbA1c,GA,CPR,TG,TC,LDL-C,HDL-C,ALT(GPT),AST(GOT),GTP,Uric acid,Creatinine,Urine microalbumin,blood pressure,adverse events | — |
Countries
Japan
Contacts
Saitama Medical University Hospital Department Endocrinology and Diabetes