UMIN ID: UMIN000048621
Registered date:08/08/2022
Add-on imeglimin versus metformin dose escalation regarding blood glucose fluctuation in patients with type 2 diabetes treated with low-dose metformin
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes |
| Date of first enrollment | 2022/08/08 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Changes of indices for glycemic variability before and after changing the treatment |
|---|---|
| Secondary Outcome | Influencing factors on changes of CGM parameters |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) History of anaphylaxis of imeglimin or metformin 2) Unstable diabetic retinopathy 3) Severe hepatic dysfunction, renal dysfunction(eGFR<45 mL/min/1.73m2) 4) Pregnancy 5) Diabetic ketosis, coma and precoma 6) Serious infection, pre-or post-surgery 7) Poor adherence to dietary therapy 8) Poor insulin secretion 9) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments |
Related Information
| Primary Sponsor | Hokkaido University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Self funding |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroshi Nomoto |
| Address | North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan Japan 060-0811 |
| Telephone | 011-706-5915 |
| hnomoto@med.hokudai.ac.jp | |
| Affiliation | Hokkaido University Hospital Department of diabetology and endocrinology |
| scientific contact | |
| Name | Hiroshi Nomoto |
| Address | North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan Japan |
| Telephone | 011-706-5915 |
| hnomoto@med.hokudai.ac.jp | |
| Affiliation | Hokkaido University Hospital Department of diabetology and endocrinology |