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

Condition(s) targeted: Non-alcoholic Fatty Liver Disease

Intervention: Liraglutide combined with metformin (Drug); Insulin glargine combined with metformin (Drug); Sitagliptin combined with metformin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Jianping Weng, Doctor, Study Director, Affiliation: Third Affiliated Hospital, Sun Yat-Sen University

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.

Official title: Efficacy of Liraglutide vs. Sitagliptin vs. Insulin Glargine Per Day on Liver Fat When Combined With Metformin in T2DM Subjects With Non-alcoholic Fatty-liver Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Intrahepatic lipids (IHL)

Secondary outcome:

Change of abdominal subcutaneous adipose tissue(SAT)

Change of visceral adipose tissue(VAT)

Change in hemoglobin A1c(HbA1c)

Detailed description: This is a 26-week, randomized, open-label, active controlled, parallel group, multi-centre trial. To compare the change of intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy(MRS) 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. The primary endpoint will be defined by intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy (MRS).

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

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

- 7%

- 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

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China; Recruiting
Hongrong Deng, PHD, Phone: 8613751863656, Email: keepon927@163.com
Xubing Yang, PHD, Phone: 8613763336436, Email: shansheep@126.com
Jinhua Yan, PHD, Sub-Investigator

Starting date: August 2014
Last updated: November 5, 2014