type 2 diabetes mellitus
Conditions
Interventions
Miglitol 150mg/day
Mitiglinide 30mg/day
Miglitol 150mg/day + Mitiglinide 30mg/day
Sponsors
Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with type 2 diabetes whose HbA1c (NGSP) was >= 6.5% but < 8.4% during prior treatment (2)Patients who are undergoing dietary/exercise therapy or biguanide therapy in addition to dietary/exercise therapy (3)Age >= 20 years (4)Patients who have the ability to provide written informed consent personally
Exclusion criteria
Exclusion criteria: (1)Patients who have undergone dietary/exercise therapy of less than 8 weeks since diabetes diagnosis (2)Patients who have undergone biguanide therapy of less than 8 weeks (3)Patients who are undergoing treatment with a sulfonylurea agent (4)Patients who are undergoing treatment with a thiazolidine agent (5)Patients who are undergoing treatment with an arufa-glucosidase inhibitor (Patients who had prior treatment with voglibose or acarbose were allowed to participate in this study, provided that 8 weeks or longer have passed since the termination of the oral treatment.) (6)Patients who are undergoing treatment with a rapid-acting insulin secretagogue (Patients who had prior treatment with nateglinide were allowed to participate in this study, provided that 8 weeks or longer have passed since the termination of the oral treatment.) (7)Patients who are undergoing concomitant treatment with an arufa-glucosidase inhibitor and a rapid-acting insulin secretagogue (8)Patients who are undergoing or who require insulin treatment (9)Patients with severe ketosis or in a diabetic coma or pre-coma (10)Patients with severe infection, perioperative, severe injury (11)Patients with history of hypersensitivity to any ingredient in the study drug (12)Women who are pregnant or who may be pregnant (13)Other patients whom their physicians in charge considered unsuitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic control meal-loading tests:plasma glucose, serum insulin, total GLP-1, total GIP HbA1c, 1,5-AG | — |
Secondary
| Measure | Time frame |
|---|---|
| high-molecular weight adiponectin, high sensitivity C reactive protein (hs-CRP), 8-Hydroxydeoxyguanosine(8-OhdG), | — |
Countries
Japan
Contacts
Public ContactMitsuru Hashiramoto
Kawasaki Medical School Division of Diabetes, Endocrinology and Metabolism
Outcome results
None listed