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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
353
Suiny 100 mg
Januvia 50 mg Glactiv 50 mg
Department of Cardiovascular Medicine, Tomishiro Central Hospital
Tomishiro, Okinawa, Japan
Change in low-density lipoprotein cholesterol
Time frame: 52-weeks
Change in glycated hemoglobin
Time frame: 52-weeks
Change in fasting glucose
Time frame: 52-weeks
Change in fasting insulin
Time frame: 52-weeks
Change in 1.5-Anhydro-D-glucitol
Time frame: 52-weeks
Change in C peptide
Time frame: 52-weeks
Change in total cholesterol, triglyceride, non high dencisty lipoprotein cholesterol
Time frame: 52-weeks
Change in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein E
Time frame: 52-weeks
Change in Apolipoprotein B48
Time frame: 52-weeks
Change in small dense low density lipoprotein
Time frame: 52-weeks
Change in high sensitivity C-reactive protein
Time frame: 52-weeks
Change in interleukin-6
Time frame: 52-weeks
Change in cholesterol absorption marker (campesterol; sitosterol)
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Time frame: 52-weeks
Change in cholesterol synthesis marker (lathosterol)
Time frame: 52-weeks
Change in high molecular weight adiponectin
Time frame: 52-weeks
Change in ratio of albumin and creatinine in urine
Time frame: 52-weeks
Progression, unchange, remission rate of microalbumin and macroalbumin in urine
Time frame: 52-weeks
Change in estimated glomerular filtration rate
Time frame: 52-weeks
Change in glycated hemoglobin stratified by body mass index and waist circumference
Time frame: 52-weeks
Correlation between glycated hemoglobin and body mass index or waist circumference
Time frame: 52-weeks
Change in intima-media thickness or flow mediated dilation
Time frame: 52-weeks
Change in postprandial glucose, insulin and activated glucagon-like peptide-1
Time frame: 52-weeks
Change in lipid profile and molecular size measured
Time frame: 52-weeks
Change in fatty acid fraction
Time frame: 52-weeks