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

Sponsor

Xijing Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03796975

Collaborator

Second Affiliated Hospital of Xi'an Jiaotong University (Other), Shaanxi Aerospace Hospital (Other), Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd (Other), Xi'an Gaoxin Hospital (Other), Chang'An Hospital (Other), Yan'an people's Hospital (Other), Shangluo Central Hospital (Other)

120

Enrollment

Location

Arms

16.8

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Non-alcoholic Fatty Liver Disease Efficacy	Drug: Combination of Pioglitazone and Metformin Tablets Drug: Metformin Hydrochloride Tablets	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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：an Multicenter，Randomized, Double-blind, Parallel- Controlled Study.

Actual Study Start Date :

Jun 28, 2018

Actual Primary Completion Date :

Apr 28, 2019

Actual Study Completion Date :

Nov 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination of Pioglitazone and Metformin Tablets 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;	Drug: Combination of Pioglitazone and Metformin Tablets 15mg/500mg, oral, 2/day Other Names: ka shuang ping
Active Comparator: Metformin Hydrochloride Tablets 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;	Drug: Metformin Hydrochloride Tablets Oral metformin 850mg, 2/day in the control group Other Names: ge hua zhi

Arm

Intervention/Treatment

Experimental: Combination of Pioglitazone and Metformin Tablets

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;

Drug: Combination of Pioglitazone and Metformin Tablets

15mg/500mg, oral, 2/day

Other Names:

ka shuang ping

Active Comparator: Metformin Hydrochloride Tablets

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;

Drug: Metformin Hydrochloride Tablets

Oral metformin 850mg, 2/day in the control group

Other Names:

ge hua zhi

Outcome Measures

Primary Outcome Measures

Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound [up to 24 weeks]
Change from baseline liver fat content to up to 24 weeks after treatment
Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index [up to 24 weeks]
Change from baseline B-cell function to up to 24 weeks after treatment
Change of liver enzyme after 24 weeks treatment as assessed by blood test [up to 24 weeks]
Change from baseline liver enzyme to up to 24 weeks after treatment

Secondary Outcome Measures

Decreased of HbA1c after 24 weeks treatment as assessed by blood test [up to 24 weeks]
Change from baseline HbA1c to up to 24 weeks after treatment
Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test [up to 24 weeks]
Change from baseline fasting blood glucose to up to 24 weeks after treatment
Change of weight and waistline after 24 weeks treatment as assessed by standard measurement [up to 24 weeks]
Change from baseline weight and waistline to up to 24 weeks after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

To meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic drugs or insulin therapy;
In accordance with the nonalcoholic fatty liver (NAFLD) criteria for the diagnosis of patients.
the level of HbA1c was 7 -10.0%;
age 18-70, body mass index 21-35kg/m2;
the subjects informed consent and signed the informed consent.

Exclusion Criteria:

type 1 diabetes or secondary diabetes;
suffering from other liver diseases, such as hepatitis, self - free liver, etc.
abnormal thyroid function (in the active period), or the need for long-term oral and intravenous glucocorticoids to treat patients;
patients with severe renal dysfunction or renal disease (eGFR<60);
in those with abnormal liver function, Alanine transaminase(ALT) or Aspartate transaminase(AST) was more than 3 times the normal upper limit.
people with serious gastrointestinal diseases such as peptic ulcers and chronic diarrhea;
patients with severe cardiopulmonary disease, cerebrovascular disease or stents;
hemopoietic system diseases such as serious primary diseases, hemoglobin < 100g/L or need regular transfusion treatment;
pregnant, breast-feeding, women of childbearing age who are unwilling to contraception during the study period;
chronic cardiac insufficiency, the classification of heart function III level and above;
uncontrolled malignant tumor, and the history of bladder cancer.
acute complications of diabetes;
the use of other drugs for diabetes and liver disease;
patients who had participated in other clinical studies within three months;
people who have known allergies to this kind of drugs are known.
it is impossible to guarantee the effect or the safety judgment of the drug or the person who is unable to cooperate with the mental illness.