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

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 4

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

Treatments: Drug: Combination of Pioglitazone and Metformin Tablets; Drug: Metformin Hydrochloride Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03796975

KY20172053-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups

Combination of Pioglitazone and Metformin Tablets

Experimental group

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;

Treatment:

Drug: Combination of Pioglitazone and Metformin Tablets

Metformin Hydrochloride Tablets

Active Comparator group

Description:

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;

Treatment:

Drug: Metformin Hydrochloride Tablets