type 2 diabetes
Conditions
Interventions
combination therapy with sitagliptin and repaglinide
monotherapy with repaglinide
Sponsors
Toho University Graduate School of Medicine.
Toranomon Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetic patients whose HbA1c level is more than 6.9 % and less than 8.4% even after diet, exercise, and administration of sitagliptin 50 mg/day. 1) HbA1c level is more than 6.9 % and less than 8.4 % for 3 months. 2) The changes in HbA1c level is plus/minus 0.5 % for 3 months. 3) Continue diet and exercise therapy for more than 6 months. 4) Taking sitagliptin for more than 3 months. 5) Biguanide or thiazolidinedione user can be included but not to change dosage and not to add-on these drugs during trial period. 6) Those who can understand the instruction and agree on the written consent.
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 100 IU/L). 4) Patients who have serious kidney disease(Serum Cr level is more than 2.0 mg/dL). 5) Patients who have serious heart disease (patients who have apparent heart failure or myocardial infarction within 3 months). 6) Patients who have serious pancreatic disease. 7) Patients with cancer. 8) Anemic patients (Hb level is less than 11g/dL). 9) Patients with thrombocytepenia (Platelet count is less than 100000/mm3) 10) Patients with serious diabetic complications including progressed neuropathy and proliferative retinopathy. 11) Patietns with serious infection, inflammation, or injury, preoperative or postoperative 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 have 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 repaglinide. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects on glucagon and insulin secretion evaluated by meal loading test. Comparison of frequency of hypoglycemic episodes during 24 weeks treatment of combination therapy and monotherapy of repaglinide. | — |
Countries
Japan
Contacts
Public ContactTakahisa Hirose MD PhD
Toho University Graduate School of Medicine. Department of Diabetes, Metabolism, and Endocrinology
Outcome results
None listed