Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, 710032, China
NCT Number: NCT03796975
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Xi'an, Shaanxi, 710032, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
15mg/500mg, oral, 2/day
Other names: ka shuang ping
Oral metformin 850mg, 2/day in the control group
Other names: ge hua zhi
Time frame: up to 24 weeks
Change from baseline liver fat content to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change from baseline B-cell function to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change from baseline liver enzyme to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change from baseline HbA1c to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change from baseline fasting blood glucose to up to 24 weeks after treatment
Time frame: up to 24 weeks
Change from baseline weight and waistline to up to 24 weeks after treatment
Xijing Hospital
Other
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:an Multicenter,Randomized, Double-blind, Parallel- Controlled Study.
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