A clinical study of a combination drug for type2 diabetes -Using self-monitoring of blood glucose and meal tolerance test
Not Applicable
- Conditions
- type2 diabetes
- Registration Number
- JPRN-UMIN000007202
- Lead Sponsor
- Advanced Clinical Research Organization
- 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
1) Patients who are applicable to the [taboo issue] in a package insert of Glubes combination tablets. Patients who have severe ketosis, precoma or diabetic coma or type 1 diabetes. Patients with severe infection or severe injury. Patients accepting surgery. Patients with a history of hypersensitivity to any component of this drug. Pregnant women and women suspected to be pregnant. 2) Patients whom the principal investigator and investigators decided not to be appropriate for taking Glubes combination tablets, on the point of [Special caution needed] and [side effects] in the package insert.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy endpoints:Blood glucose levels by SMBG. Amounts and changing value of blood glucose, insulin, proinsulin, C-peptide, glucagon, GLP-1, LDL-C, HDL-C, triglyceride, RLP-C, and free fatty acid after meal tolerance test, for each measurement point will be evaluated with descriptive statistics Amounts and changing value of HbA1c, blood glucose, glycosylated albumin and 1.5-AG for each measurement point will be evaluated with descriptive statistics Safety endpoints:The incident rate and the situation of side effects and adverse events during observation and treating periods. Laboratory evidence is the use of descriptive statistics.
- Secondary Outcome Measures
Name Time Method