Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects

NCT02147925 | Completed Phase 4

• 1 other identifier: IIS201404
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore the effectiveness of liraglutide combined with metformin in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared to sitagliptin and insulin glargine in combination with metformin.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver disease; Glucagon-like peptide-1 receptor agonists; Diabetes mellitus, type 2

Outcome Measures

Primary Outcomes (1)

• Intrahepatic lipids (IHL)

  To compare the change of intrahepatic lipids (IHL) in type 2 diabetic patients with non-alcoholic fatty-liver disease after a 26-week treatment of liraglutide, sitagliptin or insulin glargine per day combined with metformin.

  26-week

Secondary Outcomes (3)

• Change of abdominal subcutaneous adipose tissue(SAT)

  26 weeks

• Change of visceral adipose tissue(VAT)

  26 weeks

• Change in hemoglobin A1c(HbA1c)

  26 weeks

Study Arms (3)

Liraglutide

ACTIVE COMPARATOR

Liraglutide combined with metformin

Drug: Liraglutide combined with metformin

Insulin glargine

ACTIVE COMPARATOR

Insulin glargine combined with metformin

Drug: Insulin glargine combined with metformin

Sitagliptin

ACTIVE COMPARATOR

Sitagliptin combined with metformin

Drug: Sitagliptin combined with metformin

Interventions

Liraglutide combined with metformin DRUG

Liraglutide, 0.6mg per day for the first week, and will be increased to 1.2mg per day for the second week, and finally 1.8mg per day since the third week

Also known as: Victoza®, Novo Nordisk

Liraglutide

Insulin glargine combined with metformin DRUG

The initial dose will be 0.2 unit/kg/d

Also known as: Lantus®, Sanofi

Insulin glargine

Sitagliptin combined with metformin DRUG

The dose throughout the study will be 100mg per day.

Also known as: Januvia®, Merck & Co. Inc.

Sitagliptin

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recorded Type 2 diabetes diagnosed at least 3 months before the study; At least 3 months treatment on a stable dose（≧1500mg/d）of metformin before the study
• %\<HbA1c ≤10%
• Clinically diagnosed simple liver steatosis
• years old
• Female subjects should be postmenopausal, surgically sterile, or using contraceptives for 3 months before screening and continuing throughout the study;
• BMI 20\~35 kg/m2 and with a history of stable body weight (≤10%variation for ≥3 months)
• intrahepatic lipids (IHL) \>10%

You may not qualify if:

• Type 1 diabetes
• Treatment within the last 3 months with Thiazolidinediones(TZDs), orlistat, insulin, any history of incretin based therapy or any other drugs associated with hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone or methotrexate)
• History or current episode of pancreatitis or other disease of the pancrea; Impaired liver function, defined as plasma alanine transaminase(ALT) \>2.5 times of upper normal limit
• Moderate and severe renal insufficiency defined as MDRD formula glomerular filtration rate\<60ml/min/1.73m2
• Weekly alcohol intake\>14 units for women or \>21 units for men
• Any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis
• History or family history of medullary thyroid cancer(MTC), or multiple endocrine neoplasia type 2(MEN-2)
• Congestive heart failure(NYHA III\~IV)
• Severe gastric-intestinal diseases
• Pregnancy and/or intention of becoming pregnant
• Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator; Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may, at the Investigator's discretion, be continued throughout the trial at an unchanged dose

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

Metformin; Liraglutide; Insulin Glargine; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Jianping Weng, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

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: professor, vice president, the third affiliated hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 28, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 18, 2018

Record last verified: 2017-10

Locations

CN (1)