| Trial ID: | L6117 |
| Source ID: | NCT03796975
|
| Associated Drug: |
Combination Of Pioglitazone And Metformin Tablets
|
| Title: |
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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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Non-alcoholic Fatty Liver Disease|Efficacy
|
| Interventions: |
DRUG: Combination of Pioglitazone and Metformin Tablets|DRUG: Metformin Hydrochloride Tablets
|
| Outcome Measures: |
Primary: 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 | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Xijing Hospital | Collaborators: Second Affiliated Hospital of Xi'an Jiaotong University|Shaanxi Aerospace Hospital|Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd|Xi'an Gaoxin Hospital|Chang'An Hospital|Yan'an people's Hospital|Shangluo Central Hospital
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
120
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2018-06-28
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| Completion Date: |
2019-11-20
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| Results First Posted: |
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| Last Update Posted: |
2020-08-07
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| Locations: |
Xijing Hospital, Fourth Military Medical university, Xi'an, Shaanxi, 710032, China
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| URL: |
https://clinicaltrials.gov/show/NCT03796975
|
