type 2 diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Department of Medicine and Clinical Science,Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with type 2 diabetes (HbA1c 6.5-10% JDS) under life style intervention or treating with oral medicine 2)Age >=20 years, Male and Female 3)written informed consent
Exclusion criteria
Exclusion criteria: 1)type 1 diabetes 2)history of severe ketosis or diabetic coma 3)Patients having severe infection, before and after operation and trauma 4)Impaired renal function (serum-creatinine: Male >=1.5mg, Female >=1.3mg) 5)history of stroke, myocardial infarction or other severe vascular complication 6)Patients treating with DPP-IV inhibitor except for sitagliptin 7)Patients treating with gurinido or insulin at initiation time 8)patients who treated with sulfonylurea (>=glimepilide 2mg/day, >= glibenclamide 1.25mg/day or >=gliclazide 40mg/day at initiation time 9)pregnancy 10)history of anaphylaxis of itagliption 11)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent and degree of change about HbA1c when treatment begins and after 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The normal rate about HbA1c and fasting blood glucose when treatment begins and after 3, 6 or 12 months. Measure of weight, blood pressure, adverse events, pancreatic beta-cell function and lipid effects, high-sensitivity CRP, urine qualitative and microalbuminuria, 1.5AG, oxidative stress, cytokines, BNP. | — |
Countries
Japan
Contacts
Public ContactKenichi Shikata
Okayama University Hospital Centor for Innovative Clinical Medicine
Outcome results
None listed