Back to resultsEffect of Sitagliptin on Progression of Coronary Intermediate Lesion
Primary Purpose
Atherosclerosis, Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility Criteria
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.
Sites / Locations
- The General Hospital of PLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sitagliptin
Placebo
Arm Description
Sitagliptin 100mg QD
Placebo
Outcomes
Primary Outcome Measures
Changes in late lumen loss of target lesion
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 Outcome Measures
Incidence rate of MACE
MACE include composite of death, myocardial infarction, or target-vessel revascularization.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02655757
Brief Title
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion
Official Title
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion in Patients With Coronary Heart Disease Complicated With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2, 2017 (Actual)
Study Completion Date
March 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Bo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
Sitagliptin 100mg QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
JANUVIA
Intervention Description
5 mg, 1 tablet per day for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo,1 tablet per day for 12 months
Primary Outcome Measure Information:
Title
Changes in late lumen loss of target lesion
Description
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.
Time Frame
Changes from baseline in late lumen loss of target lesion at 12 months
Secondary Outcome Measure Information:
Title
Incidence rate of MACE
Description
MACE include composite of death, myocardial infarction, or target-vessel revascularization.
Time Frame
Incidence rate of MACE from baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen yundai, MD
Organizational Affiliation
The General Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The General Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion
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