Type 2 diabetes patients with CKD
Conditions
Interventions
Administration of saxagliptin 2.5mg or 5 mg once a day before breakfast.
Sponsors
Nihon University Itabashi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes 2. >=20 of age at the time of informed consent acquisition 3. HbA1c (NGSP) >=6.5% and <10.0% 4. The patients provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients who have history of hypersensitivity to saxagliptin or the other dpp-4 inhibitors 2. Patients who have history of administration of incretin-related drugs within 4 weeks 3. Patients who changed anti-diabetic drugs, diet thrapy or exercise thrapy within 4 weeks 4. Patients who have end stage renal disease undergoing maintenance dialysis, or after renal transplantation 5. Patients who have history of severe ketosis, diabetic coma, or precoma within 6 months 6. Patients who have history of cancer within 5 years 7. Patients who have liver disfunction with AST or ALT>=3 x upper limit of normal 8. Patients who experienced severe traumatotherapy requiring surgery or surgery with general anesthesia within 6 months 9. Women who is pregnant or planned to become pregnant 10. Patients who are considered not eligible for the study by the attending doctor due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean Amplitude of Glycemic Excursions from baseline to week 4 after the start of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in glucose variability and biomakers from baseline to week 4 after the start of administration | — |
Countries
Japan
Contacts
Public ContactHiroshi Fujino
Kyowa Hakko Kirin,co.,Ltd Medical Affairs Department
Outcome results
None listed