T2DM
Conditions
Interventions
After an observation period, the combination will be administered for 4 weeks, and meal load tests will be done using unified meals at the clinic before and after 4-weeks treatment.
Sponsors
Yuri Ono Clinic, Diabetes, Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)T2DM patients treated with a diabetic diet and exercise regimens for their diabetes, or, patients for whom a washout period or 4 weeks or more can be established for any hypoglycemic agent they have been treated with, other than an SU or insulin 2)Patients able to take the test meals 3)Patients age 20 years or older 4)Patients to whom the significance, objectives and methods of this study have been explained, and from whom consent can be willingly obtained
Exclusion criteria
Exclusion criteria: 1)Patients to whom [Contraindications] in labeling for the combination apply 2)Any others who the principal investigator deems unsuitable as subjects, in consideration of any [Special caution needed] in labeling for the combination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints are various metabolic parameter measures as well as changes from baseline and their AUC before and after 4-weeks treatment with the combination, and over 120 minutes after meals in the morning, afternoon and evening meals | — |
Countries
Japan
Contacts
Public ContactErika Yamagishi
Yuri Ono Clinic, Diabetes, Internal Medicine Yuri Ono Clinic, Diabetes, Internal Medicine
Outcome results
None listed