type 2 diabetes
Conditions
Interventions
Addition of 150mg/day of miglitol on basal insulin therapy of optimal diet and exercise therapy. It is probibited to add other OAD and insulin during study period.
Continuation of optimaldiet and exer
Sponsors
Dept of Medicine, Metabolisma and Endocrinology Juntendo University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)subjects whose HbA1c is 6.5-8.5% (2)subjects whose fasting blood glucose is less than 120mg/dL (3)subjects who recieved basal insulin and glimepiride therapy for more than 3 months (4)subjcets whose age are more than 20 years. (5)no restriction on gender (6)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 ilus 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) patients who have histroy of gastrectomy 15) patients with intolerance in Lactose 16) 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) 17) patients who are pregnant, hope to be pregnant, or are in lactation period 18) patients who have viral infection (HBV,HCV) 19) patients who are not applicable to this study judged by the medical doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of miglitol on glycemic control (glycated hemoglobin and postprandial glucose values evaluated with meal loading test) | — |
Secondary
| Measure | Time frame |
|---|---|
| effects of miglitol on inflammatory cytokines, adipocytokines, GLP-1, daily profile of blood glucose estimated by SMBG | — |
Countries
Japan
Outcome results
None listed