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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02330406
Other study ID # ICE_2014_01R
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2015
Est. completion date March 2019

Study information

Verified date August 2019
Source Institute for Clinical Effectiveness, Japan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 353
Est. completion date March 2019
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

1. Presence of stenosis (>=25%) or plaque on the previous coronary angiography or coronary CT

2. Presence of coronary calcification on the previous coronary CT

3. History of acute coronary syndrome

4. History of percutaneous coronary intervention or coronary artery bypass graft

5. History of stroke (ischemic stroke or hemorrhagic stroke)

6. History of transient ischemic attack

7. History of peripheral artery diseases or aortic disorders

8. Ankle-Brachial Index (AMI) equal to or less than 0.9 in the past measurement

9. 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Anagliptin
Suiny 100 mg
Sitagliptin
Januvia 50 mg Glactiv 50 mg

Locations

Country Name City State
Japan Department of Cardiovascular Medicine, Tomishiro Central Hospital Tomishiro Okinawa

Sponsors (1)

Lead Sponsor Collaborator
Institute for Clinical Effectiveness, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in low-density lipoprotein cholesterol 52-weeks
Primary Change in glycated hemoglobin 52-weeks
Secondary Change in fasting glucose 52-weeks
Secondary Change in fasting insulin 52-weeks
Secondary Change in 1.5-Anhydro-D-glucitol 52-weeks
Secondary Change in C peptide 52-weeks
Secondary Change in total cholesterol, triglyceride, non high dencisty lipoprotein cholesterol 52-weeks
Secondary Change in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein E 52-weeks
Secondary Change in Apolipoprotein B48 52-weeks
Secondary Change in small dense low density lipoprotein 52-weeks
Secondary Change in high sensitivity C-reactive protein 52-weeks
Secondary Change in interleukin-6 52-weeks
Secondary Change in cholesterol absorption marker (campesterol; sitosterol) 52-weeks
Secondary Change in cholesterol synthesis marker (lathosterol) 52-weeks
Secondary Change in high molecular weight adiponectin 52-weeks
Secondary Change in ratio of albumin and creatinine in urine 52-weeks
Secondary Progression, unchange, remission rate of microalbumin and macroalbumin in urine 52-weeks
Secondary Change in estimated glomerular filtration rate 52-weeks
Secondary Change in glycated hemoglobin stratified by body mass index and waist circumference 52-weeks
Secondary Correlation between glycated hemoglobin and body mass index or waist circumference 52-weeks
Secondary Change in intima-media thickness or flow mediated dilation 52-weeks
Secondary Change in postprandial glucose, insulin and activated glucagon-like peptide-1 52-weeks
Secondary Change in lipid profile and molecular size measured 52-weeks
Secondary Change in fatty acid fraction 52-weeks
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