Randomized Evaluation of Anagliptin Versus Sitagliptin On Low-density lipoproteiN Cholesterol in Diabetes Trial

Diabetes Mellitus Clinical Trial

— REASON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330406
• Other study ID #: ICE_2014_01R
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Dipeptidyl-Peptidase 4 Inhibitors
• Glycosylated Hemoglobin
• LDL Cholesterol

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