NCT02655757

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

December 27, 2015

Last Update Submit

January 24, 2018

Conditions

AtherosclerosisType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence rate of MACE

    Incidence rate of MACE from baseline to 12 months

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR

Sitagliptin 100mg QD

Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SitagliptinDRUG

5 mg, 1 tablet per day for 12 months

Also known as: JANUVIA
Sitagliptin
PlaceboDRUG

Placebo,1 tablet per day for 12 months

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The General Hospital of PLA

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

AtherosclerosisDiabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Chen yundai, MD

    The General Hospital of PLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 27, 2015

First Posted

January 14, 2016

Study Start

December 1, 2015

Primary Completion

February 2, 2017

Study Completion

March 10, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

CN(1)