Antidiabetic Effects on Intrahepatic Fat

NCT ID: NCT03068065

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-10-31

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.

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Liraglutide

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Gliclazide

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Victoza,Novo Nordisk; Glucophage,Bristol-Myers Squibb; Diamicron MR,Servier

Eligibility 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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Dalong Zhu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalong Zhu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

the Affiliated Drum Tower Hospital of Nanjing University

Locations

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

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

ChiCTR-TRC-14004660

Identifier Type: -

Identifier Source: org_study_id