NCT01863147

Brief Summary

Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong predictor of cardiovascular events and all-cause mortality . Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

May 21, 2013

Last Update Submit

August 15, 2015

Conditions

Newly Diagnosed Type 2 DiabetesCoronary Artery Disease

Keywords

Type 2 diabetesleft ventricular massinhibitor of dipeptidyl peptidase-4

Outcome Measures

Primary Outcomes (1)

  • Left ventricular mass and left ventricular volume

    Cardiac magnetic resonance (CMR) imaging was performed at baseline and at 12 months for left ventricular mass and left ventricular volume.

    2013~2014(follow up 1 year)

Secondary Outcomes (1)

  • Endothelial function and augmentation index (AIx)

    2013~2014 (follow up 1 year)

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin 0.1 daily for 1 year

Drug: Sitagliptin and acarbose

acarbose

ACTIVE COMPARATOR

acarbose 150mg daily for 1 year

Drug: Sitagliptin and acarbose

Interventions

Sitagliptin and acarboseDRUG

Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.

Sitagliptinacarbose

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guangda Xiang

Wuhan, Hubei, 430070, China

Location

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateAcarbose

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Xiang Guangda, MD,PhD

    Wuhan General Hospital of Guangzhou Command

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 27, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

CN(2)