Atherosclerosis, Type 2 Diabetes Mellitus
Conditions
Brief summary
This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.
Interventions
DRUGPlacebo
Placebo,1 tablet per day for 12 months
DRUGSitagliptin
5 mg, 1 tablet per day for 12 months
Sponsors
Li Bo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion.
Exclusion criteria
* Allergy or hypersensitivity to any of the drug's components. * Severe liver failure, moderate or severe kidney failure * Malignant disease. * Active infectious disease. * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in late lumen loss of target lesion | Changes from baseline in late lumen loss of target lesion at 12 months | A coronary intermediate lesion in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with 3D QCA(3D Quantitative Coronary Angiography). To measure the changes in target lumen at 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of MACE | Incidence rate of MACE from baseline to 12 months | MACE include composite of death, myocardial infarction, or target-vessel revascularization. |
Countries
China
Outcome results
None listed