The comparative study of efficacy and safety in the treatment with mixed-type insulin to combined therapy with long-acting insulin analog and GLP-1 recepter agonist in type 2 DM.
Not Applicable
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000016628
- Lead Sponsor
- Hyogo College Of Medicine Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Changes of body weight Changes of lipids Changes of the insulin dose Patient's questionnaire of QOL and feeding behavior Frequency of hypoglycemia