Type 2 diabetes
Conditions
Interventions
None listed
Sponsors
Japan Cardiovascular Research foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 less than 80 years (males and females) 3) Patients who have provided written consent to participate in the study * Except for CSII
Exclusion criteria
Exclusion criteria: 1) Patients with type 1 or secondary diabetes 2) Patients with severe infections, pre-/post-operative status, and 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 prescribed other incretin-based agents, including DPP-4 inhibitors, at study initiation 9) Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at 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 |
|---|---|
| Evaluation of cardiovascular event rates (e.g. death, acute myocardial infarction, and cerebral infarction), and correlation between the use of sitagliptin and the events | — |
Countries
Japan
Contacts
Public ContactTOMOYA MITA
Juntendo University Graduate School of Medicine Department of Medicine,Metabolism and Endocrinology
Outcome results
None listed