Type 2 diabetic patients
Conditions
Interventions
Dose increment of Sitagliptin (50mg to 100mg)
Change Sitagliptin 50mg to Linagliptin 5mg
Change Alogliptin 25mg to Linagliptin 5mg
Sponsors
Kanazawa Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)More than 20 years to less than 80 years old patient, at the time of obtaining the informed consent, (Gender, outpatient and hospitalization unquestioned) (2)Type 2 diabetes patients. (3)Patients with poorly controlled type 2 diabetes who take DPP-4 inhibitors Sitagliptin(50mg), Alogliptin (25) or Linagliptin(5) (4)Patients whose HbA1c is 7.0% <= HbA1c < 10.0% at the enrollment (5)Patients with diabetic nephropathy whose urinary albumin excretion (UAE) is >= 30 mg/gCr (6)Patients with diabetic nephropathy whose eGFRcreat is >= 30 mL/min/1.73m2 (7)Patients without changing the kind and doses of medications during the last 3 months before the enrollment (8)Patients who fully understand purpose, contents, anticipated adverse events , and risks of this clinical trial and patients with willingness to comply with the study and sign a written informed consent
Exclusion criteria
Exclusion criteria: (1)Patient who have a history of allergy to Linagliptin or Sitagliptin. (2)Patients who have severe ketosis, diabetic coma, diabetic pre-coma, or type 1 diabetes (3)Patients who have severe infection, surgery, planned surgery, severe trauma. (4)Women who are pregnant, or possibility of pregnant, or wish to pregnant, or lactating. (5)Patients with transit disorder in the digestive tract or peptic ulcer and esophageal varix (this product may irritate affected area.) and patients whom physician judges as inappropriate (6)Patients with a predisposition to severe and habitual constipation (this product may exacerbate constipation) and patients whom physician judges as inappropriate (7)Patients who are considered unsuitable for inclusion by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Plasma and urine DPP-4 activation 2)Antifibrotic miRNAs 3)Antifibrotic peptides 4)Urine IFN-gamma, IL-1 beta, sTNF-alpha reeptor1/2, IL-6, beta 2microglobulin, NAG, typeIV collagen 0 and 3 month after joining this study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Parameters of blood glucose (HbA1c, fasting blood glucose, glycoalbumin, insulin) 2)Urinary albumin excretion 3)eGFRcreat (calculation by conversion formula of GFRcreat in Japanese), serum creatinine 4)Urinary L-FABP excretion, serum cystatin C (Cys-C), eGFRcys (calculation by conversion formula of eGFRcys in Japanese) 5) Serum lipid (T-cho, LDL, HDL, TG) 6)Blood pressure, pulse | — |
Countries
Japan
Contacts
Public ContactYuka Kuroshima
Kanazawa Medical University Diabetology and Endocrinology
Outcome results
None listed