Type 2 Diabetes millitus
Conditions
Interventions
sitagliptin 50mg/day add to metformin (the patients with type 2 diabetes (6.2%<
= HbA1c(JDS) <
=10.0%) taking with metformin 500-750mg for more than 1 month treatments)
glimepiride 1mg/day add to metformin (the patients with type 2 diabetes (6.2%<
=10.0%) taking with metformin 500-750mg for more than 1 month treatments)
Sponsors
Department of Medicine and Bioregulatory,Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with type 2 diabetes (6.2%<= HbA1c(JDS) <=10.0%) taking with metformin for more than 1 month treatments. 2.Patients with the age between 20-75 years old 3.Sex: Unquestioned 4.Patients who agreed with the participation in this study with written consent
Exclusion criteria
Exclusion criteria: 1. Diabetic coma, diabetic ketoacidosis and type 1 patients 2.Patients with the severe renal impairment.(Serum creatinine >=1.5mg/dl in men and >=1.3mg/dl in women) 3.Patients with liver disfunction(ALT surpasses 3 times of normal upper limit) 4.Patient who has digestive trouble 5. In emergency cases such as severe infection and surgery 6.Patients with a history of lactic acidosis 7.The patient who has the state of being easy to be accompanied by the patient and hypoxemia which have an advanced obstacle in cardiovascular systems, such as a shock, heart failure, myocardial infarction, and pulmonary embolism, and a pulmonary function. 8.Patient Who Has Dehydration 9.Alcoholic Excessive Ingestion Patient 10.Patient of Poor Nutritional Status, Starvation, Debility State, Hypophysis Malfunction, or Adrenal-Function Insufficiency 11.Pregnant Woman or Woman that May Have Become Pregnant 12.Patients treated with Insulin preparation, alfa-glycosidase inhibitor (alfa-GI), insulin secretagogue (glinide) 13.Patient Who Has Anamnesis of Hypersensitivity to Medicine of Ingredient of Research Medicine, or the Same Action Mechanism of the Research Medicine 14.Patient Whom Family Doctor Made Unsuitable to Research Participation from Medical Rationale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the ratio and amount of change of proinsulin/IRI ratio in 12 months from the start of treatment. the ratio and amount of change of urinary microalbumin in the three-month average of 10,11,12 months after from the start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| the amount and rate of change of proinsulin/IRI ratio in 6 months from the start of treatment. the ratio and amount of change of urinary microalbumin in the three-month average between one and 12 months after from the start of treatment. the ratio and amount of change between one and 12months from the start treatment HbA1c fasting plasma glucose 1,5AG the ratio and amount of change of eGFR in 3, 6, 9, 12 months from the start of treatment the ratio and amount of change in 6, 12 months from the start of treatment hs-CRP macromolecular adiponectin 8-isoprostan glucagon bilirubin level the ratio and amount of change between one and 12 months from the start of treatment the period of the starat of insulin treatment body weight change frequency of hypoglycemia | — |
Countries
Japan
Contacts
Public ContactToyoshi Inoguchi
Graduate School of Medical Sciences, Kyushu University Department of Medicine and Bioregulatory
Outcome results
None listed