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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796975
Recruitment Status : Active, not recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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
Type2 Diabetes Mellitus Non-alcoholic Fatty Liver Disease 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.

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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 : April 20, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796975


Locations
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China, Shaanxi
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Qiuhe Ph.D Ji, M.D. Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03796975    
Other Study ID Numbers: KY20172053-1
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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