Type 2 diabetes
Conditions
Interventions
None listed
Sponsors
Department of Metabolic Medicine, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1) Type 2 diabetes patients (HbA1c (JDS value) higher than 5.8% and below 9.0%) in whom the target of blood glucose control specified in the 2010 diabetes treatment guidelines is not achieved despite dietary/exercise therapy or those with concomitant therapeutic drugs for diabetes other than a DPP-4 inhibitor being performed for 3 months or longer, including those after a 12-week or longer withdrawal of previous DPP-4 inhibitor treatment. 2) Thirty years of age or older (regardless of gender) 3) Written consent for participation in the study
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 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) Moderate renal dysfunction (Serum creatinine (mg/dL): male, 1.4<; female, 1.2<) 5) Severe liver dysfunction (AST: 100 IU/l or higher) 6) Moderate or severer heart failure) (NYHA/New York Heart Association stage III or severer) 7) Under treatment with an incretin preparation, such as other DPP-4 inhibitors, at the time of study initiation 8) Under insulin treatment 9) Under treatment with therapeutic drugs not concomitantly administrable with incretin preparations, such as DPP-4 inhibitors, with regard to national health insurance, at the time of study initiation 10) Pregnant, lactating, and possibly pregnant women and those planning to become pregnant 11) Past medical history of hypersensitivity to investigational drugs 12) Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in gray-scale median (GSM) during the 2-year observation period | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed