This is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver disease.
Taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme levels, and observed whether the drug can improve fatty liver in patients with newly diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. This is an multicenter, randomized, double-blind, parallel-controlled study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
15mg/500mg, oral, 2/day
Oral metformin 850mg, 2/day in the control group
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, China
Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound
Change from baseline liver fat content to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index
Change from baseline B-cell function to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change of liver enzyme after 24 weeks treatment as assessed by blood test
Change from baseline liver enzyme to up to 24 weeks after treatment
Time frame: up to 24 weeks
Decreased of HbA1c after 24 weeks treatment as assessed by blood test
Change from baseline HbA1c to up to 24 weeks after treatment
Time frame: up to 24 weeks
Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test
Change from baseline fasting blood glucose to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change of weight and waistline after 24 weeks treatment as assessed by standard measurement
Change from baseline weight and waistline to up to 24 weeks after treatment
Time frame: up to 24 weeks
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