Effects of a Dipeptidyl Peptidase-4 Inhibitor Sitagliptininsulin on the Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes

Phase 4

• Conditions: Atherosclerosis Type 2 Diabetes Mellitus Dipeptidyl Peptidase-4 Inhibitor GLP-1
• Interventions: Drug: Sitagliptin; Drug: Acarbose

• Registration Number: NCT03602638
• Lead Sponsor: Chinese PLA General Hospital

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.

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 Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Study Start: 2018-10-01
• Primary Completion: 2019-05-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin	Sitagliptin	-
CONTROL	Acarbose	Acarbose

Primary Outcome Measures

Name	Time	Method
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.