A clinical study of the correlation between QOL and the effects of oral anti-diabetic drugs on newly treated patients with type2 diabetes
- Conditions
- type2 diabetes
- Registration Number
- JPRN-UMIN000006986
- Lead Sponsor
- QOL study group for oral anti-diabetic agent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 800
1)Newly treated with any oral anti-diabetic drugs and inadequate glycemic control(HbA1c 6.5-9.0%[the JDS]/6.9-9.4%6.9-9.4%[the NGSP] in spite of diet and exercise therapy for over 4 weeks
2)Age of 20<=, 80>
3)Out patients of either gender
4)Patients who agree to participate in the study, and who are able to start in 12 weeks
1)type1 diabetes(CPR blood test and anti-GAD test is recommended)
2)Taking any anti-diabetic drugs
3)Severe ketosis, precoma, diabetic coma
4)Hepatic dysfunction(ALT <= 3times the upper limit of normal)
5)Gastrointestinal dysfunction as diarrhea or vomiting
6)Severe infection, severe injury. Before and after accepting surgery
7)Pregnant or suspected to be pregnant
8)History of hypersensitivity to any component of testing drugs
9)History of cancer or being treated for cancer
10)Whom the doctor in charge decided not to be appropriate for this study on the point of medical reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scores in QOL questionnaire at 4th week
- Secondary Outcome Measures
Name Time Method Scores in QOL questionnaire at 12th week<br>Analyses of each item score in the questionnaire for each drug<br>Analyses of intra-class correlation in the questionnaire for each drug<br>The changing rate of HbA1c for each drug<br>Completion rate for each drug treatment<br>Patient adherence to each drug