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Antidiabetic Effects on Intrahepatic Fat

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ClinicalTrials.gov Identifier: NCT03068065
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Type2 Diabetes Drug: Liraglutide Drug: Metformin Drug: Gliclazide Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Liraglutide
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
 Drug: Liraglutide
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 Name: Victoza,Novo Nordisk
Active Comparator: Metformin
the 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
 Drug: Metformin
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 Name: Glucophage,Bristol-Myers Squibb
Active Comparator: Gliclazide
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
 Drug: Gliclazide
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 Name: Diamicron MR,Servier


Outcome Measures
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Primary Outcome Measures :
  1. Intrahepatic fat [ Time Frame: -7±3days; 168±3days ]
    intrahepatic fat change from baseline by quantitative ultrasound


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Used antidiabetic drugs or any other possible hepatic steatosis associated with drugs within the past three months;
  2. Suffering from pancreatitis or other pancreatic diseases or have other similar history;
  3. GLP-1 analogs or sulfonylurea allergy history;
  4. Liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit);
  5. Moderate to severe renal insufficiency (eGFR<60ml/min/1.73m2,calculated according to MDRD);
  6. Female subjects drinking> 14 units / week; male subjects drinking> 21 units/week;
  7. A history of metabolic or autoimmune liver diseases or viral hepatitis diseases;
  8. A history of medullary thyroid carcinoma, multiple endocrine neoplasia 2 or family history;
  9. Congestive heart failure (NYHA grade Ⅲ - Ⅳ grade);
  10. Severe gastrointestinal diseases;
  11. Other serious concomitant diseases;
  12. Pregnant or planning pregnancy;
  13. The researchers believe that the subjects with proliferative retinopathy or macular degeneration need urgentl treatment;
  14. 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.
Contacts and Locations
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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): NCT03068065


Locations
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China, Jiangsu
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Principal Investigator: Dalong Zhu, MD,PhD the Affiliated Drum Tower Hospital of Nanjing University
More Information
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Responsible Party: Dalong Zhu, Chief physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03068065    
Other Study ID Numbers: ChiCTR-TRC-14004660
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Liraglutide
Metformin
Gliclazide
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
 Metformin
Liraglutide
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists