- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03602638
Effects of a Dipeptidyl Peptidase-4 Inhibitor Sitagliptininsulin on the Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes
July 26, 2018 updated by: Li Bo, Chinese PLA General Hospital
Chinese PLA General Hospital Hainan Branch
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 Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sitagliptin
|
Sitagliptin 100mg QD
|
Active Comparator: CONTROL
Acarbose
|
Acarbose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Changes from baseline in coronary calcification score at 18 months]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2018
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
July 19, 2018
First Submitted That Met QC Criteria
July 26, 2018
First Posted (Actual)
July 27, 2018
Study Record Updates
Last Update Posted (Actual)
July 27, 2018
Last Update Submitted That Met QC Criteria
July 26, 2018
Last Verified
July 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
- Glycoside Hydrolase Inhibitors
- Sitagliptin Phosphate
- Acarbose
Other Study ID Numbers
- ChinaPLAGH_hainan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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