Status:
COMPLETED
Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Huadong Hospital
Shanghai Minhang Central Hospital
Conditions:
Diabetes Mellitus, Type 2
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 mell...
Detailed Description
This is a randomized, open-label, parallel-group, active controlled, multi-center clinical trial to investigate whether exenatide is superior to insulin glargine in reducing liver fat content in patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02303730
Start Date
March 1 2015
End Date
November 1 2017
Last Update
August 28 2019
Active Locations (5)
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1
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
2
Department of Endocrinology and Metabolism, Shanghai Minhang Central Hospital
Shanghai, Shanghai Municipality, China
3
Department of Endocrinology and Metabolism,Huadong Hospital
Shanghai, Shanghai Municipality, China
4
Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China