Type 2 Diabetes
Conditions
Interventions
Linagliptin treatment group(Group L)
Voglibose treatment group(Group B)
Sponsors
Japan society of Patient Reported Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Drug naïve patients of type 2 Diabetes (HbA1c (NGSP value) higher than 6.2 and below 9.4) in whom the target of blood glucose control specified in the 2010 diabetes treatment guidelines is not achieved despite dietary / exercise treatment including those after a 12-week or longer withdrawal of previous drug treatment for diabetes. 2.Twenty years of age or older, regardless of gender 3.Patient with good compliance 4.Written consent for participation in the study
Exclusion criteria
Exclusion criteria: 1.Type I and secondary diabetes 2.Severe infectious disease, before or after surgery, and severe trauma 3.Events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction 4.Severe liver dysfunction (AST: 100 IU/l or higher) 5.Moderate or severer heart failure, (NYHA/New York Heart Association stage III or severer) 6.Under treatment with diabetic drugs at the time of study initiation 7.Pregnant, lactating, and possibly pregnant women and those planning to become pregnant 8.Past medical history of hypersensitivity to investigational drugs 9.Patients with cancer 10.Patent receiving steroid therapy with inflammatory affection 11.Past medical history of abdominal operation and ileus 12.Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A dietary tolerance test with a test meal will be conducted. Major evaluation items include the fasting blood glucose level early in the morning, its levels 2 hours after meals, and HbA1c at the start of administration (Week 0) and after 12 weeks. | — |
Countries
Japan
Outcome results
None listed