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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796975
• Other study ID #: KY20172053-1
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: July 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 20, 2019
• Est. primary completion date: April 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Combination of Pioglitazone and Metformin Tablets
15mg/500mg, oral, 2/day
• Metformin Hydrochloride Tablets
Oral metformin 850mg, 2/day in the control group

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical university	Xi'an	Shaanxi

Sponsors (8)

Lead Sponsor	Collaborator
Xijing Hospital	Chang'An Hospital, Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd, Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Aerospace Hospital, Shangluo Central Hospital, Xi’an Gaoxin Hospital, Yan'an people's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 24 weeks
Primary	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	up to 24 weeks
Primary	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	up to 24 weeks
Secondary	Decreased of HbA1c after 24 weeks treatment as assessed by blood test	Change from baseline HbA1c to up to 24 weeks after treatment	up to 24 weeks
Secondary	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	up to 24 weeks
Secondary	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	up to 24 weeks