Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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•Xijing Hospital

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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;
+6 more criteria

Locations (1)

Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, China

Key Dates

Start Date

June 28, 2018

Primary Completion Date

April 28, 2019

Completion Date

November 20, 2019

Last Updated

August 7, 2020

Enrollment

120

ACTUAL participants

Conditions

Type 2 Diabetes MellitusNon-alcoholic Fatty Liver DiseaseEfficacy

Interventions

Combination of Pioglitazone and Metformin Tablets

DRUG

Metformin Hydrochloride Tablets

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger

NCT07256522

Trigger FingerSplint Therapy+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger

Achieving Routine Intervention and Screening for Emotional Health

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus

Human Immunodeficiency Virus (HIV) Food Insecurities