Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Atherosclerosis
• Intervention / Treatment: Drug: Sitagliptin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • The General Hospital of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo,1 tablet per day for 12 months
Active Comparator: Sitagliptin; Sitagliptin 100mg QD	Drug: Sitagliptin; 5 mg, 1 tablet per day for 12 months; Other Names: JANUVIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of MACE	MACE include composite of death, myocardial infarction, or target-vessel revascularization.	Incidence rate of MACE from baseline to 12 months

Collaborators and Investigators

• Sponsor: Li Bo
• Investigators: Principal Investigator: Chen yundai, MD, The General Hospital of PLA

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): February 2, 2017
• Study Completion (Actual): March 10, 2017

Study Registration Dates

• First Submitted: December 27, 2015
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Atherosclerosis; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 301_xnk