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Completed

NCT Number: NCT03068065

Antidiabetic Effects on Intrahepatic Fat

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.

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Key information

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Nanjing, Jiangsu, 210008, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

liraglutide

Drug

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

Other names: Victoza,Novo Nordisk

metformin

Drug

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

Other names: Glucophage,Bristol-Myers Squibb

Gliclazide

Drug

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

Other names: Diamicron MR,Servier

Primary outcomes

  1. Intrahepatic fat

    Time frame: -7±3days; 168±3days

    intrahepatic fat change from baseline by quantitative ultrasound

Secondary outcomes

  1. Liver function

    Time frame: -7±3days; 28±3days; 84±3days; 168±3days

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

  2. Lipid

    Time frame: -7±3days; 28±3days; 84±3days; 168±3days

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

  3. Plasma glucose in standard meal tolerance test

    Time frame: -7±3days; 168±3days

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

  4. Plasma insulin in standard meal tolerance test

    Time frame: -7±3days; 168±3days

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

  5. Glucose control

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

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

  6. HbA1c

    Time frame: -7±3days; 84±3days; 168±3days

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

  7. Body composition

    Time frame: -7±3days; 168±3days

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

  8. Weight

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

    body weight

  9. WC

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

    waist circumference

Other outcomes

  1. Number of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability

    Time frame: -7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days

    adverse events caused by the drugs

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 1, 2017
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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