Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetes 2)Patients with HbA1c 7% and below 3)Patients from 20 years old but less than 80 years old at obtaining consent 4)Patients who are treated with either Dapagliflozin 5mg or Sitagliptin 50mg 5)Patients whose HbA1c is within 1% during the last 3 months 6)Patients whose medicine did not change during the last 3 months
Exclusion criteria
Exclusion criteria: 1)Type 1 diabetes or suspicion of Type 1 diabetes 2)Clinical history of hypersensitivity to SGLT2 inhibitors 3)Severe ketosis, diabetic coma or precoma 4)Severe infectious disease, pre/post-surgery or serious trauma 5)End-stage renal failure under dialysis 6)Clinical history of brain infarction or ischemic cardiac disease 7)Pulmonary embolus or severe pulmonary function impediment 8)Pituitary or adrenal gland dysfunction 9)Status of dystrophy/starvation, irregular meal intake, dietary intake deficiency or hyposthenia 10)Excessive alcohol intake 11)Dehydrated patients including those with non-functioning GIT such as diarrhea, vomiting or malignancy 12)Complicated with malignancies 13)Pregnant/ possible pregnant, breastfeeding 14)Inappropriate patients for study participation judged by principal or clinical investigator 15)Dosing of GLP-1 receptor agonist 16)Combined use of Dapagliflozin and Sitagliptin 17)Dosing of SGLT2 inhibitors other than Dapagliflozin 18)Dosing of DPPIV inhibitors other than Sitagliptin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Resistive Index: RI of renal doppler ultrasonography | — |
Secondary
| Measure | Time frame |
|---|---|
| Group comparison of the following parameters before and after treatment 1)Physical examination Body weight, BMI, blood pressure and pulse rate 2)Hematology WBC, RBC, Hb, Ht, PLT 3)Biochemistry TC, HDL-C, TG, LDL-C, Cys-C, eGFRcyc, Cr, BUN, UA, Alb, Na, K, Cl, HbA1c, fasting blood glucose 4)plasma renin activity, plasma aldosterone concentration, erythropoietin 5)BNP 6)ketone body in venous blood 7)Urinalysis urine protein, urine Cr, urine sodium, urine potassium, urine NAG, urine alpha1-MG, urine L-FABP, urine albumin, urine glucose, urine specific gravity 8)Renal doppler ultrasonography Pulsatility Index: PI, Peak Systolic Velocity: PSV, End-Diastolic Velocity: EDV, Renal Aortic Ratio: RAR, Acceleration Time: AT 9)Abdominal ultrasonography liver 10)ABI/PWV 11)Adverse events | — |
Countries
Japan
Contacts
Ogawa Red Cross Hospital Department of Internal Medicine