Trial | NCT02330406  Report issue

Title

Randomized Evaluation of Anagliptin Versus Sitagliptin On Low-density lipoproteiN Cholesterol in Diabetes Trial
Effect of Anagliptin and Sitagliptin on Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes and Cardiovascular Risk Factors: Randomized Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    353
The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin.
Diabetes is a significant cause of cardiovascular and cerebrovascular events. Especially, diabetic patients with cardiovascular risk factors were significantly higher risk for cardiovascular and cerebrovasculara event. Therefore, several medical management strategies including anti-diabetic medications and statins were considered for those patients. However, in spite of such treatment, still many patients have cardiovascular and cerebrovascular events. One of the hypothesis is the residual risk such as elevated low-density lipoprotein cholesterol (LDLC) even with statin therapy. Anagliptin, one of the dipeptidyl peptidase-4 (DPP4) inhibiors, was reported to reduce LDLC and may have pontential to decrease the cardiovascular and cerebrovascular risk for such patients on statins. We, thus, conduct a randomized controlled trial to compare Anagliptin or Sitagliptin in terms of change of LDLC for 52 weeks as well as glycemic control.
Study Started
Apr 30
2015
Primary Completion
Jan 31
2018
Study Completion
Mar 31
2019
Last Update
Aug 28
2019

Drug Anagliptin

Suiny 100 mg

  • Other names: Suiny

Drug Sitagliptin

Januvia 50 mg Glactiv 50 mg

  • Other names: Januvia, Glactiv

Anagliptin Active Comparator

Anagliptin 100 mg bid for 52 weeks. Can increase to 200 mg bid if needed.

Sitagliptin Active Comparator

Sitagliptin 50 mg qd for 52 weeks. Can increase to 100 mg qd if needed

Criteria 

Inclusion Criteria:

Patients with type 2 diabetes with cardiovascular risk factors (*) who treated with diet, exercise or antidiabetic medications
Patients who were treated with statins for 8 weeks or longer
Patients with low-density lipoprotein cholesterol equal to or greater than 100 mg/dL in the at least one of three measurements after the administration of statins
Patients with glycerated hemoglobin (HbA1c, NGSP) equal to or greater than 6.0 % (7.0 % if patients were not treated with dipeptidyl-peptidase 4 inhibitors) and lesser than 10.5 %

(*) cardiovascular risk factors were any of following conditions

Presence of stenosis (>=25%) or plaque on the previous coronary angiography or coronary CT
Presence of coronary calcification on the previous coronary CT
History of acute coronary syndrome
History of percutaneous coronary intervention or coronary artery bypass graft
History of stroke (ischemic stroke or hemorrhagic stroke)
History of transient ischemic attack
History of peripheral artery diseases or aortic disorders
Ankle-Brachial Index (AMI) equal to or less than 0.9 in the past measurement
Presence of carotid artery plaque (including Max IMT >=1.1mm) on carotid ultrasonography in the past

Exclusion Criteria:

Patients with type 1 diabetes
Patients with triglyceride equal to or greater than 400 mg/dL in the previous fasting measurements
Patients with pregnancy, possible pregnancy, or on breast-feeding
Patients with severe infections, perioperative status, or severe trauma
Patients with renal dysfunction (creatinine >= 2.4 mg/dl for men, >= 2.0 mg/dl for women)
Patients who were received glucagon-like peptide-1receptor agonists
Patients whom physician in charge considered inappropriate for the study
No Results Posted