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

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.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Efficacy
• Intervention / Treatment: Drug: Combination of Pioglitazone and Metformin Tablets; Drug: Metformin Hydrochloride Tablets

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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;	Drug: Combination of Pioglitazone and Metformin Tablets; 15mg/500mg, oral, 2/day; Other Names: ka shuang ping
Active Comparator: 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;	Drug: Metformin Hydrochloride Tablets; Oral metformin 850mg, 2/day in the control group; Other Names: ge hua zhi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Second Affiliated Hospital of Xi'an Jiaotong University; Shangluo Central Hospital; Xi'an Gaoxin Hospital; Shaanxi Aerospace Hospital; Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd; Chang'An Hospital; Yan'an people's Hospital
• Investigators: Principal Investigator: Qiuhe Ph.D Ji, M.D., Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): April 28, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Type 2 Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Pioglitazone
• Other Study ID Numbers: KY20172053-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No