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

Phase 4

Completed

• Conditions: Non-alcoholic Fatty Liver Disease; Type 2 Diabetes Mellitus; Efficacy
• Interventions: Drug: Combination of Pioglitazone and Metformin Tablets; Drug: Metformin Hydrochloride Tablets

• Registration Number: NCT03796975
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2018-06-28
• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-08
• Primary Completion: 2019-04-28
• Study Completion: 2019-11-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of Pioglitazone and Metformin Tablets	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;
Metformin Hydrochloride Tablets	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;

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xijing Hospital, Fourth Military Medical university; 🇨🇳 Xi'an, Shaanxi, China