UMIN ID: UMIN000002077
Registered date:17/06/2009
A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus |
| Date of first enrollment | 2010/07/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Percentage of patients who reach target HbA1c under 6.5% |
|---|---|
| Secondary Outcome | 1. Change of HbA1c, 1.5AG, fasting plasma glucose, 7-point SMBG, 2-hour postprandial glucose level 2. Hypoglycemia episodes and other adverse events 3. Markers of cardiovascular risk [Human sensitive C-reactive peptide (hsCRP), Soluble Intercellular Adhesion Molecule(sICAM), soluble vascular cell adhesion molecule 1 (sVCAM-1) and von Willebrand Factor (vWF)] 4. Circumference of waist and hip 5. Change of height, weight, BMI 6. Change of insulin dose (total dose, basal dose, bolus dose) 7. Change of patients' QOL and satisfaction |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patients who have experience of insulin treatment 2. Pregnant, or intention of becoming pregnant. 3. Patients who are judged by investigators as inappropriate subject to participant this trail. |
Related Information
| Primary Sponsor | Tokyo Women's Medical University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomoko Nakagami |
| Address | 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan Japan |
| Telephone | 03-3353-8111 |
| nakagami@dmc.twmu.ac.jp | |
| Affiliation | Tokyo Women's Medical University Diabetes Center |
| scientific contact | |
| Name | Yasuhiko Iwamoto |
| Address | 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan Japan |
| Telephone | 03-3353-8111 |
| Affiliation | Tokyo Women's Medical University Diabetes Center |