Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effect of Sitagliptin on Progression of Coronary Intermediate Lesion in Patients With Coronary Heart Disease Complicated With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655757
• Other study ID #: 301_xnk
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2015
• Last updated: January 24, 2018
• Start date: December 2015
• Est. completion date: March 10, 2017

Study information

• Verified date: January 2018
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 10, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
5 mg, 1 tablet per day for 12 months
• Placebo
Placebo,1 tablet per day for 12 months

Locations

Country	Name	City	State
China	The General Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Li Bo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Changes from baseline in late lumen loss of target lesion at 12 months
Secondary	Incidence rate of MACE	MACE include composite of death, myocardial infarction, or target-vessel revascularization.	Incidence rate of MACE from baseline to 12 months