Type 2 diabetes
Conditions
Interventions
Group receiving sitagliptin (DPP-4 inhibitor treated group)
Group receiving standard treatment (non-DPP-4 inhibitor treated group)
Sponsors
Study group for diabetes mellitus and vascular lesion secretariat
Hokkaido univ,Akita univ,Dokkyo Medical univ,Tskuba univ,Showa univ,Nippon Medical univ,Tokyo Wemen'
s Medical univ,Juntendo univ,Tokyo Medical univ,Yokohama City univ,Mie univ,Osaka univ,etc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes who had received diet and exercise therapy or diet, exercise and pharmacologic therapy with oral antidiabetic agents other than a DPP-4 inhibitor for more than 3 months and whose blood glucose have not been sufficiently controlled (5.8% <= HbA1c(JDS) < 9.0%) 2) Outpatients aged >= 30 years of both sexes 3) Patients who have given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients with type 1 diabetes 2) Patients who had a history of severe ketosis, diabetic coma or precoma within 6 months 3) Patients before or after operation, and those with severe infections or serious injury 4) Patients with severe kidney dysfunction (eGFR: <30 mL/min or patients under dialysis) 5) Patients who had myocardial infarction, angina, percutaneous transluminal coronary angioplasty / bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient cerebral ischemic attack within 3 months before the study initiation. 6) Patients with moderate or severe cardiac dysfunction (NYHA class III or IV) 7) Patients who are being treated with a DPP-4 inhibitor or glucagon-like peptide-1 (GLP-1) analog at the time of the study initiation 8) Patients who are being treated with insulin at the time of the study initiation 9) Pregnant, possible pregnant, or lactating women 10) Patients with a history of hypersensitivity to the study drug 11) Patients who are considered not eligible for the study by the attending doctor due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The % changes of the mean IMT value after 24 months from the baseline which assessed by ultrasonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The measured value of ultrasonography and the % changes and variation at the point of baseline, and at after 12 and 24 months. Common carotid artery: excluding the % of changes at the point of 24 months. Sphere, Internal carotid artery: the maximum IMT value, plaque area, plaque luminance 2) Laboratory test values indicated below at baseline, and after 12 and 24 months, and changes and %changes in the values from baseline. NT-proBNP, high-sensitivity CRP, 1,5AG, small-dense LDL, high-molecular-weight adiponectin, RLP-C, and MDA-LDL 3) Laboratory test values indicated below at baseline, and after 3, 6, 12 and 24 months, and changes and %changes in the values from baseline. HbA1c, fasting blood glucose, insulin, serum lipids (TC,HDL-C, and TG), serum creatinine, urinary albumin excretion (creatinine corrected value), eGFR (converted value), HOMA-beta and HOMA-R (converted values) and cystatin C 4) Cardiovascular function parameters indicated below at baseline, and after 12 and 24 months, and changes and %changes in the values from baseline. Echocardiogram (systolic and diastolic function, left atrial dimension, and left ventricular mass index), flow-mediated dilation (FMD), pulse wave velocity (PWV), cardio-ankle vascular Index (CAVI), and atherogenic index (AI) 5) Values indicated below at baseline, and after 3, 6, 12 and 24 months, changes and %changes in the values from baseline, and incidence of significant clinical symptoms. Blood pressure (ambulant), weight and incidence of significant weight change, and incidence of hypoglycemia symptoms | — |
Countries
Japan
Contacts
Public ContactJunichi Oyama
Study group for diabetes mellitus and vascular lesion Secretariat
Outcome results
None listed