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NCT Number: 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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Combination of Pioglitazone and Metformin Tablets

Drug

15mg/500mg, oral, 2/day

Other names: ka shuang ping

Metformin Hydrochloride Tablets

Drug

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

Other names: ge hua zhi

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

  • 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

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2019
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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