Status:
COMPLETED
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
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Second Affiliated Hospital of Xi'an Jiaotong University
Shaanxi Aerospace Hospital
Conditions:
Type 2 Diabetes Mellitus
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 diagn...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03796975
Start Date
June 28 2018
End Date
November 20 2019
Last Update
August 7 2020
Active Locations (1)
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1
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, China, 710032