UMIN ID: UMIN000010409
Registered date:03/04/2013
Clinical study on glycemic excursion improvements with a fixed mitiglinide / voglibose combination in patients with type 2 diabetic mellitus(T2DM) - research into glycemic excursion-improving mechanisms -
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | T2DM |
| Date of first enrollment | 2013/03/18 |
| Target sample size | 12 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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. |
Outcome(s)
| Primary Outcome | 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 |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Yuri Ono Clinic, Diabetes, Internal Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Advanced Clinical Research Organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Erika Yamagishi |
| Address | 1-7, Nishi 3, Kita 2, Chuo-Ku, Sapporo Japan |
| Telephone | 011-223-5152 |
| erika-yamagishi@npo-acro.jp | |
| Affiliation | Yuri Ono Clinic, Diabetes, Internal Medicine Yuri Ono Clinic, Diabetes, Internal Medicine |
| scientific contact | |
| Name | Yuri Ono |
| Address | 1-7, Nishi 3, Kita 2, Chuo-Ku, Sapporo Japan |
| Telephone | 011-223-5152 |
| erika-yamagishi@npo-acro.jp | |
| Affiliation | Yuri Ono Clinic, Diabetes, Internal Medicine Director |