Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

Li Bo

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Atherosclerosis

Treatments: Drug: Placebo; Drug: Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02655757

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Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Sitagliptin

Active Comparator group

Description:

Sitagliptin 100mg QD

Treatment:

Drug: Sitagliptin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo