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

• ClinicalTrials.gov Identifier: NCT03796975
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: August 7, 2020
• Sponsor: Xijing Hospital
• Collaborators: Second Affiliated Hospital of Xi'an Jiaotong University; Shaanxi Aerospace Hospital; Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd; Xi'an Gaoxin Hospital; Chang'An Hospital; Yan'an people's Hospital; Shangluo Central Hospital
• Information provided by (Responsible Party): Xijing Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Efficacy	Drug: Combination of Pioglitazone and Metformin Tablets; Drug: Metformin Hydrochloride Tablets	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: June 28, 2018
• Actual Primary Completion Date: April 28, 2019
• Actual Study Completion Date: November 20, 2019

Arms and Interventions

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 Name: 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 Name: ge hua zhi

Outcome Measures

Primary Outcome Measures :

1. Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound [ Time Frame: up to 24 weeks ]
   Change from baseline liver fat content to up to 24 weeks after treatment
2. Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index [ Time Frame: up to 24 weeks ]
   Change from baseline B-cell function to up to 24 weeks after treatment
3. Change of liver enzyme after 24 weeks treatment as assessed by blood test [ Time Frame: up to 24 weeks ]
   Change from baseline liver enzyme to up to 24 weeks after treatment

Secondary Outcome Measures :

1. Decreased of HbA1c after 24 weeks treatment as assessed by blood test [ Time Frame: up to 24 weeks ]
   Change from baseline HbA1c to up to 24 weeks after treatment
2. Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test [ Time Frame: up to 24 weeks ]
   Change from baseline fasting blood glucose to up to 24 weeks after treatment
3. Change of weight and waistline after 24 weeks treatment as assessed by standard measurement [ Time Frame: up to 24 weeks ]
   Change from baseline weight and waistline to up to 24 weeks after treatment

Eligibility Criteria

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

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.

Contacts and Locations

Locations

China, Shaanxi

Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Xijing Hospital

Second Affiliated Hospital of Xi'an Jiaotong University

Shaanxi Aerospace Hospital

Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd

Xi'an Gaoxin Hospital

Chang'An Hospital

Yan'an people's Hospital

Shangluo Central Hospital

Investigators

• Principal Investigator: Qiuhe Ph.D Ji, M.D.; Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University

More Information

• Responsible Party: Xijing Hospital
• ClinicalTrials.gov Identifier: NCT03796975
• Other Study ID Numbers: KY20172053-1
• First Posted: January 8, 2019
• Last Update Posted: August 7, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xijing Hospital:

Type 2 Diabetes Mellitus; Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets; Randomized Controlled Trial; Non-alcoholic Fatty Liver Disease

Additional relevant MeSH terms:

Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Digestive System Diseases; Metformin; Pioglitazone; Hypoglycemic Agents; Physiological Effects of Drugs