Antidiabetic Effects on Intrahepatic Fat

Non-Alcoholic Fatty Liver Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068065
• Other study ID #: ChiCTR-TRC-14004660
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2017
• Last updated: February 28, 2017
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

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 ? - ? 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease
• Type2 Diabetes

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability	adverse events caused by the drugs	-7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days
Primary	Intrahepatic fat	intrahepatic fat change from baseline by quantitative ultrasound	-7±3days; 168±3days
Secondary	Liver function	serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST)	-7±3days; 28±3days; 84±3days; 168±3days
Secondary	Lipid	total cholesterol (CH), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL)	-7±3days; 28±3days; 84±3days; 168±3days
Secondary	Plasma glucose in standard meal tolerance test	plasma glucose was measured at 0, 30, 60, and 120 min after ingestion of the meal	-7±3days; 168±3days
Secondary	Plasma insulin in standard meal tolerance test	plasma insulin was measured at 0, 30, 60, and 120 min after ingestion of the meal	-7±3days; 168±3days
Secondary	Glucose control	fasting blood glucose (FBG), postprandial blood glucose (PBG)	14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
Secondary	HbA1c	glycosylated hemoglobin A 1c (HbA1c) was measured by high-performance liquid chromatography	-7±3days; 84±3days; 168±3days
Secondary	Body composition	fat mass and lean tissue were measured by dual-energy X-ray absorptiometry	-7±3days; 168±3days
Secondary	Weight	body weight	14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
Secondary	WC	waist circumference	14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days