Antidiabetic Effects on Intrahepatic Fat

NCT03068065 | Completed Phase 4 DMC

• 1 other identifier: ChiCTR-TRC-14004660
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Type2 Diabetes

Keywords

Liraglutide; Metformin; Gliclazide

Outcome Measures

Primary Outcomes (1)

• Intrahepatic fat

  intrahepatic fat change from baseline by quantitative ultrasound

  -7±3days; 168±3days

Secondary Outcomes (9)

• Liver function

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

• Lipid

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

• Plasma glucose in standard meal tolerance test

  -7±3days; 168±3days

• Plasma insulin in standard meal tolerance test

  -7±3days; 168±3days

• Glucose control

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

Other Outcomes (1)

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

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

Study Arms (3)

Liraglutide

ACTIVE COMPARATOR

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

Metformin

ACTIVE COMPARATOR

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

Gliclazide

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Victoza,Novo Nordisk

Liraglutide

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

Also known as: Glucophage,Bristol-Myers Squibb

Metformin

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

Also known as: Diamicron MR,Servier

Gliclazide

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Liraglutide; Metformin; Gliclazide

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Biguanides; Guanidines; Amidines; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Dalong Zhu, MD,PhD

  the Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 1, 2017
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2015
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

CN (1)