Type 2 Diabetes
Conditions
Interventions
A group of increasing metformin up to 1500mg
A group of add-on Linagliptin
Sponsors
Japan society of Patient Reported Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only those meet the following criteria will be qualified for this study; Inclusion Criteria: 1.Type 2 Diabetes with HbA1c (NGSP) 6.0% or higher and below 8.5% 2.NAFLD (Bright liver found with ultrasonic examination and AST or ALT is twice higher or greater than normal ranges, which differ from hospital to hospital) 3.PT-INR International normalized ratio< 1.7, ALB> 3.5g/dL, TB< 1.5mg/dL 4.eGFR is 50mL/min/1.73m&sup2; or higher 5.Has no previous metformin experience, or has metformin 750mg or less per day without other medicine for diabetes at screening 6.Alcohol intake: No excess of 20g per day for men and 10g per day for women 7. Men or women aged 20 to 74 8. 18< BMI< 35 9. Agree with diet therapy before and during the experiment
Exclusion criteria
Exclusion criteria: Person who correspond to any of following will be excluded; Exclusion Criteria; 1.Type1 diabetes or secondary diabetes 2.Current use of warfarin potassium 3.Hepatitis B surface antigen positive or HCV antibody positive 4.Has severe injury, severe infection or an operation scheduled within one year 5.MI, AP, or CI in 12 weeks before obtaining informed consent 6.Atrial fibrillation or frequent ventricular ectopy 7.Moderate or greater cardiac insufficiency ,stage 3 or higher of New York Heart Association classification. 8.AST or ALT is 5 times higher or greater than normal values ,values differ among the hospitals 9.Alpha1 antitrypsin deficiency,Wilson's disease,primary biliary cirrhosis(PBC),or serum creatinine is twice higher than normal values 10.Ascites, encephalopathia 11.Possible labile hypertension or instability lipid abnormality found twelve weeks before obtaining informed consent 12.Alcohol or drug addiction 13.Pregnant, breast feeding, or possible pregnancy 14.Anyone who falls into contraindicated conditions 15.Any condition that may raise doctor concern
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of fat amount and means in the liver at 52 weeks from baseline measured with computer technology | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Division of clinical study support
Outcome results
None listed