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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03602638
Recruitment Status : Unknown
Verified July 2018 by Li Bo, Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Li Bo, Chinese PLA General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Type 2 Diabetes Mellitus Dipeptidyl Peptidase-4 Inhibitor GLP-1 Drug: Sitagliptin Drug: Acarbose Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chinese PLA General Hospital Hainan Branch
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sitagliptin Drug: Sitagliptin
Sitagliptin 100mg QD
Active Comparator: CONTROL
Acarbose
 Drug: Acarbose
Acarbose


Outcome Measures
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Primary Outcome Measures :
  1. coronary calcification score [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602638


Contacts
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Contact: LI BO, MD +86089837330575 22401919@qq.com

Sponsors and Collaborators
Chinese PLA General Hospital
More Information
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Responsible Party: Li Bo, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03602638    
Other Study ID Numbers: ChinaPLAGH_hainan
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sitagliptin Phosphate
 Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycoside Hydrolase Inhibitors