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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

Primary Purpose

Type 2 Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Efficacy

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Combination of Pioglitazone and Metformin Tablets

Metformin Hydrochloride Tablets

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, Randomized Controlled Trial, Non-alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Xijing Hospital, Fourth Military Medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination of Pioglitazone and Metformin Tablets

Metformin Hydrochloride Tablets

Arm Description

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;

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;

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Decreased of HbA1c after 24 weeks treatment as assessed by blood test

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

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

Change from baseline weight and waistline to up to 24 weeks after treatment

Full Information

NCT ID

NCT03796975

First Posted

November 11, 2018

Last Updated

August 5, 2020

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

1. Study Identification

Unique Protocol Identification Number

NCT03796975

Brief 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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 28, 2018 (Actual)

Primary Completion Date

April 28, 2019 (Actual)

Study Completion Date

November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Efficacy

Keywords

Type 2 Diabetes Mellitus, Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, Randomized Controlled Trial, Non-alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination of Pioglitazone and Metformin Tablets

Arm Type

Experimental

Arm Description

Arm Title

Metformin Hydrochloride Tablets

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Combination of Pioglitazone and Metformin Tablets

Other Intervention Name(s)

ka shuang ping

Intervention Description

15mg/500mg, oral, 2/day

Intervention Type

Drug

Intervention Name(s)

Metformin Hydrochloride Tablets

Other Intervention Name(s)

ge hua zhi

Intervention Description

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

Primary Outcome Measure Information:

Title

Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound

Description

Change from baseline liver fat content to up to 24 weeks after treatment

Time Frame

up to 24 weeks

Title

Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index

Description

Change from baseline B-cell function to up to 24 weeks after treatment

Time Frame

up to 24 weeks

Title

Change of liver enzyme after 24 weeks treatment as assessed by blood test

Description

Change from baseline liver enzyme to up to 24 weeks after treatment

Time Frame

up to 24 weeks

Secondary Outcome Measure Information:

Title

Decreased of HbA1c after 24 weeks treatment as assessed by blood test

Description

Change from baseline HbA1c to up to 24 weeks after treatment

Time Frame

up to 24 weeks

Title

Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test

Description

Change from baseline fasting blood glucose to up to 24 weeks after treatment

Time Frame

up to 24 weeks

Title

Change of weight and waistline after 24 weeks treatment as assessed by standard measurement

Description

Change from baseline weight and waistline to up to 24 weeks after treatment

Time Frame

up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiuhe Ph.D Ji, M.D.

Organizational Affiliation

Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital, Fourth Military Medical university

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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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