Clinical trial NCT03796975: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Shaanxi Aerospace Hospital
name: Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd
name: Xi'an Gaoxin Hospital
name: Chang'An Hospital
name: Yan'an people's Hospital
name: Shangluo Central Hospital
First posted: 2019-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound
timeFrame: up to 24 weeks
measure: Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index
timeFrame: up to 24 weeks
measure: Change of liver enzyme after 24 weeks treatment as assessed by blood test
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Decreased of HbA1c after 24 weeks treatment as assessed by blood test
timeFrame: up to 24 weeks
measure: Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test
timeFrame: up to 24 weeks
measure: Change of weight and waistline after 24 weeks treatment as assessed by standard measurement
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical university
state: Shaanxi
Study officials:
affiliation: Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University
name: Qiuhe Ph.D Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
References: