Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients who have given written informed consent for participation in this study. 2)Patients can be of either sex. 3)Patients must be at least 20 years old on the date of giving informed consent. 4) Patients must not have taken thiazolidinediones or dipeptidyl peptidase-4 -inhibitors within 3 months before admission to hospital or later. However, other antidiabetic agents are not problematic. 5) At admission to hospital, patients must have a glycosylated hemoglobin (HbA1c) level, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases, of 6.9% to 10.4%. At admission to hospital, patients must have had diabetes for less than 10 years. 6) In the case of patients with whom glucotoxicity has been eliminated as far as possible, using rapid-acting insulin, ultra-rapid-acting insulin, or sulfonylurea agents, and who thus have fasting blood sugar levels of 126 mg/dL or lower, the blood sugar level 2 hours after a meal must be at least 180 mg/dL.
Exclusion criteria
Exclusion criteria: 1)Patients with type-1 diabetes; diabetes due to pancreatic disorder; or secondary diabetes, due to Cushings syndrome, acromegaly, etc. 2)Patients to whom the contraindications in the Package Insert apply. 3)Patients are classed as having excessive alcohol consumption if their mean daily intake of pure alcohol is 60 g or higher, this being equivalent to three cups of sake, one cup of shochu (a Japanese spirit), three medium-sized bottles of beer, three whiskey or brandy doubles, or five glasses of wine. 4)Patients who are or may be pregnant, or are breastfeeding. 5) Patients whose participation in the study is judged by the Investigator or Sub-Investigator to be inappropriate for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Active GLP1 concentration Total and active GIP concentration Change in postprandial glucose( For 5 days) Change in HbA1c(For 3 months) | — |
Countries
Japan
Contacts
Hyogo college of medicine Dept. of Diabetes, Endocrinology and Metabolism