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Antidiabetic Effects on Intrahepatic Fat

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Type2 Diabetes

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Liraglutide

Metformin

Gliclazide

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Liraglutide, Metformin, Gliclazide

Eligibility Criteria

17 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Liraglutide

Metformin

Gliclazide

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Intrahepatic fat

intrahepatic fat change from baseline by quantitative ultrasound

Secondary Outcome Measures

Liver function

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

Lipid

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

Plasma glucose in standard meal tolerance test

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

Plasma insulin in standard meal tolerance test

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

Glucose control

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

HbA1c

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

Body composition

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

Weight

body weight

waist circumference

Full Information

NCT ID

NCT03068065

First Posted

February 16, 2017

Last Updated

February 28, 2017

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1. Study Identification

Unique Protocol Identification Number

NCT03068065

Brief Title

Antidiabetic Effects on Intrahepatic Fat

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease, Type2 Diabetes

Keywords

Liraglutide, Metformin, Gliclazide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liraglutide

Arm Type

Active Comparator

Arm Description

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

Arm Title

Metformin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Gliclazide

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

Liraglutide

Other Intervention Name(s)

Victoza,Novo Nordisk

Intervention Description

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

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage,Bristol-Myers Squibb

Intervention Description

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

Intervention Name(s)

Gliclazide

Other Intervention Name(s)

Diamicron MR,Servier

Intervention Description

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

Primary Outcome Measure Information:

Title

Intrahepatic fat

Description

intrahepatic fat change from baseline by quantitative ultrasound

Time Frame

-7±3days; 168±3days

Secondary Outcome Measure Information:

Title

Liver function

Description

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

Time Frame

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

Title

Lipid

Description

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

Time Frame

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

Title

Plasma glucose in standard meal tolerance test

Description

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

Time Frame

-7±3days; 168±3days

Title

Plasma insulin in standard meal tolerance test

Description

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

Time Frame

-7±3days; 168±3days

Title

Glucose control

Description

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

Time Frame

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

Title

HbA1c

Description

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

Time Frame

-7±3days; 84±3days; 168±3days

Title

Body composition

Description

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

Time Frame

-7±3days; 168±3days

Title

Weight

Description

body weight

Time Frame

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

Title

Description

waist circumference

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

adverse events caused by the drugs

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dalong Zhu, MD,PhD

Organizational Affiliation

the Affiliated Drum Tower Hospital of Nanjing University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Antidiabetic Effects on Intrahepatic Fat

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