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

NCT ID: NCT03796975

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-28
• Study Completion Date: 2019-11-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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;

Group Type: EXPERIMENTAL

Combination of Pioglitazone and Metformin Tablets

Intervention Type: DRUG

15mg/500mg, oral, 2/day

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;

Group Type: ACTIVE_COMPARATOR

Metformin Hydrochloride Tablets

Intervention Type: DRUG

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

Interventions

Combination of Pioglitazone and Metformin Tablets

15mg/500mg, oral, 2/day

Intervention Type: DRUG

Metformin Hydrochloride Tablets

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

Intervention Type: DRUG

Other Intervention Names

ka shuang ping; ge hua zhi

Eligibility Criteria

Inclusion Criteria

1. To meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic drugs or insulin therapy;

2. In accordance with the nonalcoholic fatty liver (NAFLD) criteria for the diagnosis of patients.

3. the level of HbA1c was 7 -10.0%;

4. age 18-70, body mass index 21-35kg/m2;

5. the subjects informed consent and signed the informed consent.

Exclusion Criteria

1. type 1 diabetes or secondary diabetes;

2. suffering from other liver diseases, such as hepatitis, self - free liver, etc.

3. abnormal thyroid function (in the active period), or the need for long-term oral and intravenous glucocorticoids to treat patients;

4. patients with severe renal dysfunction or renal disease (eGFR<60);

5. in those with abnormal liver function, Alanine transaminase(ALT) or Aspartate transaminase(AST) was more than 3 times the normal upper limit.

6. people with serious gastrointestinal diseases such as peptic ulcers and chronic diarrhea;

7. patients with severe cardiopulmonary disease, cerebrovascular disease or stents;

8. hemopoietic system diseases such as serious primary diseases, hemoglobin < 100g/L or need regular transfusion treatment;

9. pregnant, breast-feeding, women of childbearing age who are unwilling to contraception during the study period;

10. chronic cardiac insufficiency, the classification of heart function III level and above;

11. uncontrolled malignant tumor, and the history of bladder cancer.

12. acute complications of diabetes;

13. the use of other drugs for diabetes and liver disease;

14. patients who had participated in other clinical studies within three months;

15. people who have known allergies to this kind of drugs are known.

16. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Shaanxi Aerospace Hospital

UNKNOWN

Sponsor Role: collaborator

Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Xi'an Gaoxin Hospital

OTHER

Sponsor Role: collaborator

Chang'An Hospital

OTHER

Sponsor Role: collaborator

Yan'an people's Hospital

UNKNOWN

Sponsor Role: collaborator

Shangluo Central Hospital

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiuhe Ph.D Ji, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37305429 (View on PubMed)

Other Identifiers

KY20172053-1

Identifier Type: -

Identifier Source: org_study_id