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| Name | Class |
|---|---|
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Shaanxi Aerospace Hospital | UNKNOWN |
| Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of Pioglitazone and Metformin Tablets | Experimental | dosage form: tablet; dosage:15mg/500mg; frequency: the dose in week 1 is 15mg/500mg, once a day, increased to 15mg/500mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral; |
|
| Metformin Hydrochloride Tablets | Active Comparator | dosage form: tablet; dosage: 850mg; frequency: the dose in week 1 is 850mg, once a day, increased to 850mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Pioglitazone and Metformin Tablets | Drug | 15mg/500mg, oral, 2/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decreased of HbA1c after 24 weeks treatment as assessed by blood test | Change from baseline HbA1c to up to 24 weeks after treatment | up to 24 weeks |
| Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiuhe Ph.D Ji, M.D. | Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital, Fourth Military Medical university | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37305429 | Derived | Jianfang F, Wanxia X, Xiling G, Jing X, Wenjuan Y, Jianrong L, Qingzhen H, Kaiyan M, Jingxuan L, Taixiong C, Qian X, Mengying L, Jie M, Qiuhe J. Effect and Safety of Pioglitazone-Metformin Tablets in the Treatment of Newly Diagnosed Type 2 Diabetes Patients with Nonalcoholic Fatty Liver Disease in Shaanxi Province: A Randomized, Double-Blinded, Double-Simulated Multicenter Study. J Diabetes Res. 2023 Jun 1;2023:2044090. doi: 10.1155/2023/2044090. eCollection 2023. |
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| Xi'an Gaoxin Hospital |
| OTHER |
| Chang'An Hospital | OTHER |
| Yan'an People's Hospital | OTHER |
| Shangluo Central Hospital | OTHER |
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| Metformin Hydrochloride Tablets | Drug | Oral metformin 850mg, 2/day in the control group |
|
|
Change from baseline fasting blood glucose to up to 24 weeks after treatment
| 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 | up to 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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