Type 2 diabetes
Conditions
Interventions
Sitagliptin 50 mg Orally administration once a day
Ipragliflozin 50 mg Orally administration once a day, pre or post breakfast
Sponsors
Niigata University Fuculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Inclusion criteria before initiation of metformin monotherapy ] 1) Type 2 diabetes 2) Aged from 20 to 80 years at providing consent 3) With poorly glycemic controlled, nevertheless undergo diet and exercise therapy or administrated oral hypoglycemic agents 4) HbA1c >= 6.5% and <10.0% 5) Provided written informed consent [Inclusion criteria at randomization] 6) Patients who are only administrated identical dose of metformin (>= 500 mg/day) for 8 weeks or more 7) HbA1c >= 6.5% and <10.0%
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma within 6 months from the day of providing consent 3) With severe infection, pre or post surgery, and serious trauma 4) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.3 mg/dL, female: >= 1.2 mg/dL) 5) With severe hepatic disorder 6) Has history of stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization 7) Has history of lactic acidosis 8) Patients who drink excessive alcohol 9) Has urinary tract infection, genital infection and dehydration at providing consent 10) Administrated insulin, GLP-1 receptor agonist within 1 year 11) Is pregnant, nursing, possibly pregnant and planned to become pregnant 12) Has history of hypersensitivity to SGLT-2 inhibitors, DDP-4 inhibitors and BG 13) Considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of percentage of patients who achieve the following items 52 weeks after randomization 1) Decreased HbA1c values by 0.5% or more 2) No increase of body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Comparison of percentage of patients achieved following items after 12, 24 and 36 weeks from randomization 1. Decrease of >= 0.5% HbA1c 2. No increase of body weight 2) Comparison of change or percent change of following items after 4, 12, 24, 36 and 52 weeks from randomization 1. HbA1c, fasting plasma glucose, blood insulin/serum C-pepitide (Fasting) 2. Body weight, BMI, waist circumference 3. Serum lipid (Fasting TG, TC, LDL-C, HDL-C) 4. SBP/DBP (Casual blood pressure) 5. Urinary albumin, transferrin, NAG, electrolyte (Na, K, Cl) (Spot urine) 6. Target level achievement rate (HbA1c, blood pressure, lipid etc.) 7. JJ risk engine score Above data are summarized and analysed stratified by patient characteristics such as occupation, employment situation and lifestyle (Diet and exercise). | — |
Countries
Japan
Contacts
Public ContactNaoto Sano
Niigata University Medical and Dental Sciences Administration Division
Outcome results
None listed