Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPIKE Sub Study
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000028664
- Lead Sponsor
- Department of Metabolic Medicine, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 274
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change in gray-scale median (GSM) during the 2-year observation period
- Secondary Outcome Measures
Name Time Method