Effects of a Dipeptidyl Peptidase-4 Inhibitor Sitagliptininsulin on the Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes
Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03602638
Collaborator
(none)
300
2
26
Study Details
Study Description
Brief Summary
This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Chinese PLA General Hospital Hainan Branch
Anticipated Study Start Date
:
Oct 1, 2018
Anticipated Primary Completion Date
:
May 1, 2019
Anticipated Study Completion Date
:
Dec 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sitagliptin
|
Drug: Sitagliptin
Sitagliptin 100mg QD
|
| Active Comparator: CONTROL Acarbose |
Drug: Acarbose
Acarbose
|
Outcome Measures
Primary Outcome Measures
- coronary calcification score [Changes from baseline in coronary calcification score at 18 months]]
Changes in coronary calcification score in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with Computed tomography angiography. To measure the changes in coronary calcification score at 18 months.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Patients > 18, < 80 years old, with type 2 diabetes mellitus and coronary heart disease.
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chinese PLA General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Li Bo,
Li Bo,
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT03602638
Other Study ID Numbers:
- ChinaPLAGH_hainan
First Posted:
Jul 27, 2018
Last Update Posted:
Jul 27, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: