Observational Study of ASCVD Risks of Type 2 Diabetes in East China

Zhejiang Provincial People's Hospital

Status: Not yet enrolling

Conditions: Liraglutide; Type 2 Diabetes Mellitus; Arteriosclerotic Cardiovascular Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04866667

zjPPHNFM001

Details and patient eligibility

About

The aim of this study is to screen patients with type 2 diabetes with high risk of cardiovascular disease, and intervene with or without Glucagon like peptide-1 receptor agonists.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes

• HbA1c ≥7.0%

• Prior CVD cohort: age ≥50 and ≥1 of the following criteria.

  • Prior MI
  • Prior stroke or TIA
  • Prior coronary, carotid or peripheral arterial revascularization
  • N50% stenosis of coronary, carotid, or lower extremity arteries
  • History of symptomatic CHD documented by Positive exercise stress test or any cardiac imaging or Unstable angina with ECG changes
  • Asymptomatic cardiac ischemia Documented by positive nuclear imaging test, exercise test or dobutamine stress echo
  • Chronic heart failure NYHA class II-III
  • Chronic renal failure, eGFR <60 mL/min per 1.73m2 MDRD eGFR <60 mL/min per Cockcroft-Gault formula

• No Prior CVD group: Age ≥60 y and ≥1 of the following criteria.

  • Microalbuminuria or proteinuria
  • Hypertension and left ventricular hypertrophy by ECG or imaging
  • Left ventricular systolic or diastolic dysfunction by imaging
  • Ankle-brachial index b0.9

Exclusion criteria

• Type 1 diabetes
• other type diabetes
• Calcitonin ≥50 ng/L
• Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any DPP-4 inhibitor within the 3 months prior to screening
• Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Shortterm use of other insulin during this period in connection with intercurrent illness is allowed, at Investigators discretion
• Acute decompensation of glycemic control
• An acute coronary or cerebrovascular event in the previous 14 d
• Currently planned coronary, carotid, or peripheral artery revascularization
• Chronic heart failure (NYHA class IV)
• Current continuous renal replacement therapy
• End-stage liver disease
• History of solid organ transplant or awaiting solid organ transplant
• Malignant neoplasm
• Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
• Personal history of non-familial medullary thyroid carcinoma

Trial design

800 participants in 2 patient groups

antidiabetic drugs including GLP-1 RAs

Description:

Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs including GLP-1 RAs

antidiabetic drugs not including GLP-1 RAs

Description:

Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs not including GLP-1 RAs，such as metformin，insulin