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Type 2 Diabetes MellitusPhase 4NCT03796975

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

A Phase 4 study testing Combination of Pioglitazone and Metformin Tablets and Metformin Hydrochloride Tablets in people with Type 2 Diabetes Mellitus and Non-alcoholic Fatty Liver Disease, run by Xijing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Combination of Pioglitazone and Metformin Tablets and Metformin Hydrochloride Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
28 Jun 2018to 20 Nov 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital, Fourth Military Medical university

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

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.

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.

Read the 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.

Being tested
Combination of Pioglitazone and Metformin Tablets, Metformin Hydrochloride Tablets
Keywords
Type 2 Diabetes Mellitus, Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, Randomized Controlled Trial, Non-alcoholic Fatty Liver Disease
Medical subject headings
Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination of Pioglitazone and Metformin TabletsDrug

    Also called ka shuang ping

    15mg/500mg, oral, 2/day

  • Metformin Hydrochloride TabletsDrug

    Also called ge hua zhi

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

Study groups in NCT03796975
Study groupRoleWhat they receive
Combination of Pioglitazone and Metformin TabletsExperimentaldosage 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;
Receives: Drug: Combination of Pioglitazone and Metformin Tablets
Metformin Hydrochloride TabletsActive comparatordosage 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;
Receives: Drug: Metformin Hydrochloride Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 24 weeks

  2. 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

    Measured: up to 24 weeks

  3. 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

    Measured: up to 24 weeks

Secondary outcomes (3)

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

    Change from baseline HbA1c to up to 24 weeks after treatment

    Measured: up to 24 weeks

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

    Change from baseline fasting blood glucose to up to 24 weeks after treatment

    Measured: up to 24 weeks

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

    Change from baseline weight and waistline to up to 24 weeks after treatment

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start28 Jun 2018
  3. Primary completion28 Apr 2019
  4. Study completion20 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03796975
Sponsor's protocol ID
KY20172053-1
Status last verified
Jul 2020
First submitted
11 Nov 2018
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37305429

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combination of Pioglitazone and Metformin Tablets and Metformin Hydrochloride Tablets in people with Type 2 Diabetes Mellitus and Non-alcoholic Fatty Liver Disease, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound (time frame: up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03796975, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.

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