Study on insulin treatment for type 2 diabetes performed by general practitioners
Not Applicable
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000011287
- Lead Sponsor
- General incorporated Tokyo Physicians Association.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Females during pregnancy or lactation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in HbA1c from baseline at the specified measurement times (every four weeks)
- Secondary Outcome Measures
Name Time Method - Changes in HbA1c from baseline (Week 0) at the specified measurement times (every four weeks) in patients undergoing insulin therapy with the study drug - Changes from baseline in self-measurement of blood glucose (SMBG) (wake up time, SMBG for five days of the week before or/and after the specified day) at specified measurement times (every four weeks) - Changes in the dose of the study drug at specified measurement times (every four weeks) - Changes from baseline (Week 0) in early-morning fasting blood glucose level and BMI at study completion (Week 12) - Changes from baseline (Week 0) in liver function, renal function, and lipid test values at study completion (Week 12) - Information on onset of hypoglycemia