type 2 diabetes
Conditions
Interventions
thrice daily biphasic insulin aspart 70/30
thrice daily ultra-rapid insulin aspart
Sponsors
Dept of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetes patients whose glycated hemoglobin level are between 6.5 and 8.0 % 2)glycated hemoglobin level were stable during last three months (-0.5 to 0.5%) 3)subjects who are already performing diet and exercise therapy for 6 months 4)subjects who were prescribed only ultra rapid insulin thrice daily for more than 6 months 5)no ristriction on the drugs already prescribed but no allowance to stop them or change the doses of them. It is possible to change those to avoid adverse effects like hypoglycemia 6)subjcets whose age are more than 20 years. 7)no restriction on gender 8)subjects who chan understand informed consent
Exclusion criteria
Exclusion criteria: 1) type 1 diabetes 2) patients who have serious liver disease (AST and/or ALT are more than 100IU/L) 3) patients who have serious kidney disease (Serum Cr is more than 2.0mg/dL) 4) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months) 5) patients who have serious pancreatic disease 6) patients with cancer 7) anemic patients (Hb is less than 11g/dL) 8) patients with thrombocytepenia (Platelet count is less than 100000/mm3) 9) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy 10) patietns with serious infection, inflammation, or injuary. pre- or post- operative state 11) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus 12) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome 13) patients who has the disease which is deteriorated with increase of gas in bowel 14) heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day) 15) patients who are pregnant, hope to be pregnant, or are in lactation period 16) patients who have viral infection (HBV,HCV) 17) patients who are not applicable to this study judged by the medical doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparison of glycemic control(HbA1c, BSDP monitored by SMBG, and safety (frequency of hypoglycemia) | — |
Secondary
| Measure | Time frame |
|---|---|
| influence on atheregenic infectious marker and total dose of daily insulin | — |
Countries
Japan
Outcome results
None listed