Type 2 Diabetes
Conditions
Interventions
Group A: Administer linagliptin After randomization, patients in this group start linagliptin from 5 mg once a day for 24 weeks.
Group B: Administer metformin After randomization, patients in th
Sponsors
Juntendo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Japanese patients with type 2 diabetes who have not achieved the target blood glucose level that is specified in the Treatment Guide for Diabetes 2014-2015 [HbA1c (NGSP) level of 6.0% or higher] 2. Patients newly starting diabetic treatment with an oral antidiabetic drug in addition to diet and exercise therapies 3. Patients who were 20-year old or older, and younger than 75-year old at the time of consent 4. Patients who can consent in writing
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in OHA-Q score (total score) at the observation point of week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed