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Non-Alcoholic Fatty Liver DiseasePhase 4NCT03068065

Antidiabetic Effects on Intrahepatic Fat

A Phase 4 study testing Liraglutide, Metformin and Gliclazide in people with Non-Alcoholic Fatty Liver Disease and Type2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease. Read more about this study

Who is it for?
Ages 17 to 80 years
What is being tested?
Liraglutide, Metformin and Gliclazide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteChina
Study dates
May 2014to Oct 2015
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 17 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age: 18-70 years;
  • Type 2 diabetes mellitus;
  • Not used antidiabetic drugs within 3 months;
  • HbA1c(7-10%);
  • Presence of fatty liver disease (hepatic fat content ≥ 20% by quantitative ultrasonography);
  • Female subjects：post-menopausal women, take contraceptive measures three months before the test screening and can persist throughout the experimental period;
  • Body mass index (BMI) 20-35kg/m2, and stable Weight 3 months(less than 10% volatility);
  • patients signed the informed consent.

Who cannot join

  • Used antidiabetic drugs or any other possible hepatic steatosis associated with drugs within the past three months;
  • Suffering from pancreatitis or other pancreatic diseases or have other similar history;
  • GLP-1 analogs or sulfonylurea allergy history;
  • Liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit);
  • Moderate to severe renal insufficiency (eGFR<60ml/min/1.73m2,calculated according to MDRD);
  • Female subjects drinking> 14 units / week; male subjects drinking> 21 units/week;
Show all 14Show fewer
  • A history of metabolic or autoimmune liver diseases or viral hepatitis diseases;
  • A history of medullary thyroid carcinoma, multiple endocrine neoplasia 2 or family history;
  • Congestive heart failure (NYHA grade Ⅲ - Ⅳ grade);
  • Severe gastrointestinal diseases;
  • Other serious concomitant diseases;
  • Pregnant or planning pregnancy;
  • The researchers believe that the subjects with proliferative retinopathy or macular degeneration need urgentl treatment;
  • Subjects are using unknown ingredients or non herbal medicine preparations or local medicine, researchers believe that during the test the dose of traditional Chinese medicines can not be adjusted or disabled.

Trial locations and contacts

1 site in 1 country.

China1 site

  • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD)

This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.

Read the detailed description

Following enrollment, eligible participants were randomized (1:1:1) using computer-generated random numbers to the metformin (Glucophage, Bristol-Myers Squibb), liraglutide (Victoza, Novo Nordisk), or gliclazide (Diamicron, Servier) groups. All patients were informed about a proper diet and exercise. For the metformin group (n = 31), the dosage was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study. For the gliclazide group (n = 31), the initial dosage was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L. For the liraglutide group (n = 31), the dosage was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study.At the end of the study, data will be collected and analyzed.

Being tested
Liraglutide, Metformin, Gliclazide
Keywords
Liraglutide, Metformin, Gliclazide
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

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

  • LiraglutideDrug

    Also called Victoza,Novo Nordisk

    the dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study

  • MetforminDrug

    Also called Glucophage,Bristol-Myers Squibb

    the dosage of metformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study

  • GliclazideDrug

    Also called Diamicron MR,Servier

    the initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L

Study groups in NCT03068065
Study groupRoleWhat they receive
LiraglutideActive comparatorthe dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study
Receives: Drug: Liraglutide
MetforminActive comparatorthe dosage of merformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study
Receives: Drug: Metformin
GliclazideActive comparatorthe initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L
Receives: Drug: Gliclazide

What is being measured

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

  1. Intrahepatic fat

    intrahepatic fat change from baseline by quantitative ultrasound

    Measured: -7±3days; 168±3days

Secondary outcomes (9)

  1. Liver function

    serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST)

    Measured: -7±3days; 28±3days; 84±3days; 168±3days

  2. Lipid

    total cholesterol (CH), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL)

    Measured: -7±3days; 28±3days; 84±3days; 168±3days

  3. Plasma glucose in standard meal tolerance test

    plasma glucose was measured at 0, 30, 60, and 120 min after ingestion of the meal

    Measured: -7±3days; 168±3days

  4. Plasma insulin in standard meal tolerance test

    plasma insulin was measured at 0, 30, 60, and 120 min after ingestion of the meal

    Measured: -7±3days; 168±3days

  5. Glucose control

    fasting blood glucose (FBG), postprandial blood glucose (PBG)

    Measured: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days

  6. HbA1c

    glycosylated hemoglobin A 1c (HbA1c) was measured by high-performance liquid chromatography

    Measured: -7±3days; 84±3days; 168±3days

  7. Body composition

    fat mass and lean tissue were measured by dual-energy X-ray absorptiometry

    Measured: -7±3days; 168±3days

  8. Weight

    body weight

    Measured: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days

  9. WC

    waist circumference

    Measured: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days

Timeline

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

  1. First posted1 Mar 2017
  2. Study startMay 2014
  3. Primary completionNov 2014
  4. Study completionOct 2015

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
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03068065
Sponsor's protocol ID
ChiCTR-TRC-14004660
Status last verified
Feb 2017
First submitted
16 Feb 2017
Last updated
1 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide, Metformin and Gliclazide in people with Non-Alcoholic Fatty Liver Disease and Type2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 8 inclusion and 14 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 1 Mar 2017. 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?

Intrahepatic fat (time frame: -7±3days; 168±3days). 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 NCT03068065.

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 1 Mar 2017.

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Antidiabetic Effects on Intrahepatic Fat (NCT03068065) | AzTrials