Type 2 Diabetes Mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The patients with type 2 diabetes mellitus treated with twice daily insulin injection of premixed insulin value of HbA1c more than 7.0% value of BMI more than 22
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus Subjects who have been experienced severe ketosis, diabetic coma or precoma within 6 months Subjects in pregnant women, lactating women, the potential or planned are pregnant Subjects with severe infection, before and just after surgery or severe injury Subjects treated with adrenocorticosteroid Subjects with severe hepatic dysfunction Subjects with impaired insulin secretion Subjects with a history of pancreatitis or with a pancreatitis Subjects with a history of a malignant tumor or with a malignant tumor Subjects who have been determined to be unsuitable for the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of HbA1c, GA and 1.5-AG Changes of the fasting blood glucose level Changes of 2 hours postprandial blood glucose level Achievement of HbA1c less than 7% Changes of SMBG | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of body weight Changes of lipids Changes of the insulin dose Patient's questionnaire of QOL and feeding behavior Frequency of hypoglycemia | — |
Countries
Japan
Contacts
Hyogo College Of Medicine Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine