type 2 diabetes
Conditions
Interventions
combination therapy with vildagliptin and nateglinide
monotherapy with vildagliptin
Sponsors
Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: the patients whose HbA1c level is more than 6.5% and less than 8.4% even after diet, excise, and administration of nateglinide
Exclusion criteria
Exclusion criteria: 1) type 1 diabetes 2) patients who has been prescribed sulfonylurea or alpha glucosidase inhibitor 3) patients who have serious liver disease (AST and/or ALT are more than 80IU/L) 4) patients who have serious kidney disease (Serum Cr is more than 1.5mg/dL) 5) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months) 6) patients who have serious pancreatic disease 7) patients with cancer 8) anemic patients (Hb is less than 11g/dL) 9) patients with thrombocytepenia (Platelet count is less than 100000/mm3) 10) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy 11) patietns with serious infection, inflammation, or injuary. pre- or post- operative state 12) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus 13) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome 14) patients who has the disease which is deteriorated with increase of gas in bowel 15) 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) 16) patients who are pregnant, hope to be pregnant, or are in lactation period 17) patients who have viral infection (HBV,HCV) 18) patients who are not applicable to this study judged by the medical doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of changes of HbA1c and meal loading test after 24 weeks treatment of combination therapy and monotherapy of vildagliptin | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of frequency of hypoglycemic episodes during 24 weeks treatment of combination therapy and monotherapy of vildagliptin. Effects on glucagon and insulin secretion evaluated by meal loading test | — |
Countries
Japan
Outcome results
None listed