The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QO
- Conditions
- Type 2 Diabetes
- Registration Number
- JPRN-UMIN000022953
- Lead Sponsor
- Juntendo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with type 1 diabetes or secondary diabetes 2. Patients show an acute diabetic complication within 6 weeks before consenting to participate in the study 3. Patients with congestive heart failure or myocardial infarction requiring drug therapy 4. Patients with unstable angina and those who underwent coronary artery bypass surgery within 6 months before consent was acquired 5. Patients with hepatic cirrhosis or chronic active hepatitis 6. Patients with moderate to severe renal dysfunction and undergoing dialysis 7. Patients with ALT or AST levels that are at least 3-fold higher than the reference levels (>=3 X ULN) 8. Direct bilirubin levels at least 3-fold higher than the reference levels (>=3 X ULN), with clinically significant changes in TSH levels, or with fasting triglyceride levels of >7.9 mmol/l 9. Patients who have previously used an antidiabetic drug 10. Patients with dementia or with probable dementia and those with a psychiatric illness 11. Patients who lack the ability to make judgments and those who are unable to read and write 12. Patients requiring a legally acceptable representative 13. Patients who are or may be pregnant, or breastfeeding 14. If the study drug is contraindicated to use 15. Patients with a malignant tumor or a history of a malignant tumor (however, patients who are not currently undergoing treatment for a malignant tumor and who do not appear and are not likely to have any recurrence during the study period may be included.) 16. Other conditions that are considered inappropriate to participate by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in OHA-Q score (total score) at the observation point of week 24
- Secondary Outcome Measures
Name Time Method The following outcomes from baseline to week 24 are evaluated: 1) OHA-Q, changed values of each domain score 2) Changed value of DTR-QOL (total score, each domain score) 3) Changed value of HbA1c 4) Prevalence of the patients (%) achieved the target HbA1c level (HbA1c< 6.0%, HbA1c< 7.0%, or HbA1c improved 0.5% or more) 5) Changed value of glucose level at fasting state 6) Prevalence of the patients (%) achieved HbA1c< 7.0% and improved their QOL scores 7) Incidence rate of hypoglycemia 8) Incidence rate of adverse events found in digestive system (diarrhea, nausea, vomiting) 9) Hospitalization (%) due to heart failure 10) Incidence rate of other adverse events