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. Patients with type 2 diabetes (HbA1c [JDS value] of 6.6% or above) who do not show achievement of the target for glycemic control defined in the "Treatment Guide for Diabetes 2010" despite the three or more months of insulin therapy* (one to four injections per day during treatment with rapid-acting, ultra-rapid-acting, long-acting, intermediate-acting, or mixed insulin) or insulin therapy combined with oral diabetic agents other than DPP-4 inhibitors. Those who had previously used DPP-4 inhibitors but have not taken them for the recent twelve or more weeks are also included. 2. Patients aged 30 or older and younger than 80 years old (males and females) 3. Patients who have provided written consent to participate in the study *Excluding CSII
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 or secondary diabetes 2. Patients with severe infections, pre-/post-operative status, or serious injuries 3. Patients with previous events of myocardial infarction, angina pectoris, stroke, or cerebral infarction 4. Patients complicated with diabetic retinopathy requiring retinal photocoagulation or crystalline lens surgery, or those who have undergone these treatments within the last one year 5. Patients with moderate or more severe renal dysfunction (serum creatinine [mg/dL] > 1.4 [male] or > 1.2 [female]) 6. Patients with severe liver dysfunction (AST: 100 IU/l or above) 7. Patients with moderate or more severe heart failure (NYHA [New York Heart Association] class of III or above) 8. Patients who are prescribed with incretin-based agents, including other DPP-4 inhibitors at the time of commencement of the study 9. Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at the study initiation 10. Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant 11. Patients with previous hypersensitivity to the investigated drug 12. Other patients determined ineligible by an investigator
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