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

NCT03796975 | Completed Phase 4 DMC

• 1 other identifier: KY20172053-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Decreased of HbA1c after 24 weeks treatment as assessed by blood test

  up to 24 weeks

• Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test

  up to 24 weeks

• Change of weight and waistline after 24 weeks treatment as assessed by standard measurement

  up to 24 weeks

Study Arms (2)

Combination of Pioglitazone and Metformin Tablets

EXPERIMENTAL

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

Metformin Hydrochloride Tablets

ACTIVE COMPARATOR

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

Interventions

Combination of Pioglitazone and Metformin Tablets DRUG

15mg/500mg, oral, 2/day

Also known as: ka shuang ping

Combination of Pioglitazone and Metformin Tablets

Metformin Hydrochloride Tablets DRUG

Oral metformin 850mg, 2/day in the control group

Also known as: ge hua zhi

Metformin Hydrochloride Tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic drugs or insulin therapy;
• In accordance with the nonalcoholic fatty liver (NAFLD) criteria for the diagnosis of patients.
• the level of HbA1c was 7 -10.0%;
• age 18-70, body mass index 21-35kg/m2;
• the subjects informed consent and signed the informed consent.

You may not qualify if:

• type 1 diabetes or secondary diabetes;
• suffering from other liver diseases, such as hepatitis, self - free liver, etc.
• abnormal thyroid function (in the active period), or the need for long-term oral and intravenous glucocorticoids to treat patients;
• patients with severe renal dysfunction or renal disease (eGFR\<60);
• in those with abnormal liver function, Alanine transaminase(ALT) or Aspartate transaminase(AST) was more than 3 times the normal upper limit.
• people with serious gastrointestinal diseases such as peptic ulcers and chronic diarrhea;
• patients with severe cardiopulmonary disease, cerebrovascular disease or stents;
• hemopoietic system diseases such as serious primary diseases, hemoglobin \< 100g/L or need regular transfusion treatment;
• pregnant, breast-feeding, women of childbearing age who are unwilling to contraception during the study period;
• chronic cardiac insufficiency, the classification of heart function III level and above;
• uncontrolled malignant tumor, and the history of bladder cancer.
• acute complications of diabetes;
• the use of other drugs for diabetes and liver disease;
• patients who had participated in other clinical studies within three months;
• people who have known allergies to this kind of drugs are known.

Sponsors & Collaborators

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

Study Sites (1)

Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Jianfang F, Wanxia X, Xiling G, Jing X, Wenjuan Y, Jianrong L, Qingzhen H, Kaiyan M, Jingxuan L, Taixiong C, Qian X, Mengying L, Jie M, Qiuhe J. Effect and Safety of Pioglitazone-Metformin Tablets in the Treatment of Newly Diagnosed Type 2 Diabetes Patients with Nonalcoholic Fatty Liver Disease in Shaanxi Province: A Randomized, Double-Blinded, Double-Simulated Multicenter Study. J Diabetes Res. 2023 Jun 1;2023:2044090. doi: 10.1155/2023/2044090. eCollection 2023.

  PMID: 37305429 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Qiuhe Ph.D Ji, M.D.

  Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: January 8, 2019
• Study Start: June 28, 2018
• Primary Completion: April 28, 2019
• Study Completion: November 20, 2019
• Last Updated: August 7, 2020

Record last verified: 2020-07

Locations

CN (1)