Type 2 diabetes
Conditions
Interventions
switching from twice-daily 250mg-metformin to once-daily 25mg-alogliptin/250mg-metformin combination tablets over 12 weeks
switching from twice-daily 250mg-metformin to twice-daily 100mg-anagliptin/2
Sponsors
Fujisawa City Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes ; age between 20 and 75 years 2) Patients with twice-daily 250mg-metformin more than 8 weeks before intervention 3) Patients who showed HbA1c levels 7.0% to 11.0% after 8 weeks metformin therapy 4) Patients without change of oral anti-diabetic medications over 8 weeks before intervention
Exclusion criteria
Exclusion criteria: 1) Patients with DPP-4 inhibitor, GLP-1 receptor agonist, or insulin therapy 2) Patients with severe renal dysfunction (eGFR <30ml/min/1.73m2) 3) Patients with severe liver dysfunction 4) Patients with severe infection, operation, trauma 5) Patients with steroid medication 6) Patients who have pregnancy or possibilty of pregnancy, or are under lactation 7) Patients who have hypersensitivity to metformin, alogliptin, or anagliptin 8) Patients who are considered to be not eligible to the study by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing the two groups change in HbA1c over the 12-week treatment period, with a non-inferiority margin of 0.4% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medication adherence 2. Fasting blood glucose (mg/dL) 3. Body weight (kg) | — |
Countries
Japan
Contacts
Public ContactShunsuke Yamazaki
Fujisawa City Hospital Department of Diabetes and Endocrinology
Outcome results
None listed