Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether exenatide is superior to insulin glargine (after 24 weeks) in reducing liver fat content (by MRS) in patients with newly diagnosed type 2 diabetes mellitus and concomitant non-alcoholic fatty-liver disease(NAFLD).

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

Details

• Lead Sponsor: Fudan University
• Collaborators: Huadong Hospital; Shanghai 6th People's Hospital; Shanghai Changzheng Hospital; Shanghai Minhang Central Hospital
• Treatments: Exenatide; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Male or female, 18 ≤ age ≤ 70 years old.

• Newly diagnosed type 2 diabetes mellitus (WHO Diagnostic criteria for diabetes mellitus, 1999).

• Patients with NAFLD, MRS measurement of liver fat content> 10%.

• 7% ≤ HbA1c ≤ 10%

• No heavy drinking history within the last 5 years (alcohol intake: male < 20 g/d, female < 10 g/d)

• HBsAg (-), hepatitis C virus antibody (HCV-Ab) (-)

• BMI ≥ 24 kg/m2;

Exclusion Criteria:

• Pregnancy, lactation, intended pregnancy, or failure to take adequate contraceptive measures taken (contraception measures including sterilization, intrauterine device, oral contraceptives, and persistent use of condoms).

• Type 1 diabetes mellitus, gestational diabetes mellitus or other special types of diabetes.

• Liver and renal dysfunction (ALT or aspartate aminotransferase(AST) is 2.5 times higher than the upper limit of normal, or total bilirubin is 1.5 times higher than the upper limit of normal, or Cr ≥ 115 μmol/L).

• increased amylase (blood amylase is 2.5 times higher than the upper limit of normal) or presence of gastrointestinal disease.

• Use of drugs that may affect liver fat content within one month before or during the trial period, such as glucocorticoids, thyroid hormone, etc.

• Use of GLP-1 receptor agonist, dipeptidyl peptidase -4 (DPP-4) inhibitors or insulin within 3 months before enrolment

• Presence of serious dyslipidemia or other endocrine diseases (hypothyroidism, hypothalamic-pituitary dysfunction, etc).

• Fatty liver caused by viral hepatitis, drug, alcohol, Wilson disease or total parenteral nutrition.

• Presence of liver cancer, infection, biliary tract disease or recently increased liver enzyme due to medication.

• Participation in strenuous exercise or administration of any drugs that affect glucose metabolism.

• History of pancreatitis, alcohol abuse, metal disorders or history of allergy to investigational drug.

• Congestive heart failure defined as New York Heart Association (NYHA) class III or IV, unstable angina or myocardial infarction in recent 6 months.

• Any situation that may affect the implementation or results of the study.