T2DM
Conditions
Interventions
After an observation period of DPP-4 inhibitor treatment, patients are randomly assigned to two groups, co-administration with the combination for 2 times per day or 3 times per day for 2 2-weeks trea
Sponsors
Yuri Ono Clinic, Diabetes, Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) T2DM patients who are insufficient glycaemic control, during treatment of a DPP-4 inhibitor for 8 weeks or more under a diet and exercise therapy 2) Patients who are able to take the test meals 3) Patients whose age are 20 years or older 4) Patients who have been explained the purpose, objectives and methods of this study, and submitted the written informed consent to participate the study.
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 the actual measured value of glycemic/metabolic parameters over 120 minutes after each meal, the changes from baseline and the AUC over 120 minutes after each meal of breakfast, lunch and dinner in each treatment period. | — |
Countries
Japan
Contacts
Public ContactYuri Ono
Yuri Ono Clinic, Diabetes, Internal Medicine Director
Outcome results
None listed