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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Liraglutide; Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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

• 6.5%- Clinically diagnosed simple liver steatosis

• 30-75 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%

Exclusion Criteria:

• 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